The Vice President of Business Development is responsible for meeting the Sales Quota provided by their manager to drive business growth. Identifying new markets, new partnerships, new ways to reach existing markets or service offerings to better meet the needs of customers is key to meeting or exceeding the Sales Quota. The incumbent will be accountable for tracking their progress against the Sales Quota and providing ongoing updates which are tracked and maintained in customer relationship management (CRM) system by the incumbent. Incumbent will work proactively with appropriate division management and related support departments to ensure client needs are met or exceeded.

• Develops and executes a growth strategy in collaboration with the leadership’s goals, objectives, and financial and utilization targets
• Enters, tracks and regularly monitors status of goals, opportunities in CRM by updating the information in order to provide regular updates to Executive Leadership and management
• Build and proactively nurture solid business relations with key decision makers who influence the purchase of our services
• Reviews and analyzes sales and operational records and reports; uses data to project sales, determine profitability and targets, and identify potential new markets
• Consults with potential customers to understand their needs; identifies and suggests services that will meet those needs
• Resolves customer complaints, and other issues that may interfere with efficient sales operations
• Provides information, quotes, credit terms, and other bid specifications to new customers and/or existing clients
• Negotiates prices, terms of sales, and/or service agreements; prepares contracts and submits orders. Manage proposal response process including detailed RFP requirements, content creation and inputs from various sources
• Collaborates with purchasing departments, managers, and other staff to confirm that orders are processed with accuracy and efficiency and that products are distributed properly
• Build long-term relationships with new and existing customers
• Represent company at tradeshows and other professional activities
• Develop and maintain comprehensive knowledge of competitive products and their activity in the marketplace
• Must be capable of overnight travel up to 50% of the time; or as required
• Performs other duties as required
• Account responsibility for East Coast Life Sciences companies only

Required Knowledge/Abilities: 

• This position requires a minimum of a bachelor’s degree and/ or relevant experience
• Proficient in strategic account management & planning Required Skills
• Skilled with Microsoft office applications such as Word, Excel PowerPoint) and ability to present work in report formats.
• Strong organizational, analytical and collaboration skills
• Excellent communication and follow-up skills
• Experience using customer relationship management (CRM) software, such as Salesforce
• Proven experience and aptitude to meet, interact, and present in front of a wide range of customers
• Capacity to make independent sound decisions and independently manage priorities
• Proven attention to detail and organization (including technical proofreading, follow-through, and communication)
• Ability to role model the Verista Values
• Experience working in a fast paced, high growth, results driven organization
• Ideal candidate will be able to leverage an existing personal network of industry contacts to immediately produce leads and opportunities for client companies located geographically on the East Coast 

Senior Buyer Responsibilities:

• Maintain and update material master data, supplier records, and pricing conditions in SAP (MM required; PM preferred) to ensure accurate procurement and system data integrity
• Support supplier onboarding and Third-Party Due Diligence (TPDD) activities, ensuring required documentation and approvals are completed prior to supplier activation
• Create, manage, and track purchase orders for direct materials, monitoring supplier confirmations, delivery schedules, and expediting orders as necessary to maintain supply continuity
• Ensure accurate pricing and procurement records, investigating and resolving invoice discrepancies in collaboration with suppliers and Accounts Payable
• Collaborate cross-functionally with Manufacturing, Planning, Quality, Engineering, and Finance to support material availability and operational needs
• Maintain procurement documentation and system records in compliance with GMP, GxP, and internal quality standards, ensuring audit readiness within a regulated environment

Requirements:

• Bachelor’s degree in Supply Chain Management, Business Administration, Engineering, or a related discipline
• 5+ years of procurement or supply chain experience, preferably supporting direct materials within a GMP-regulated pharmaceutical or biotechnology environment
• Hands-on experience using SAP (MM required; PM preferred) for material master data, supplier management, and purchase order processing
• Familiarity with supplier onboarding, third-party due diligence (TPPD), and procurement documentation within regulated environments
• Strong organizational, analytical, and cross-functional communication skills, with the ability to manage multiple priorities and maintain accurate, audit-ready procurement records
• Ability to be on-site, full-time, in Devens, MA

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
• Ensure deviations are thoroughly documented, investigated, and closed within required timelines
• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support validation impact assessments and execution activities related to changes
• Review and approve validation and technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
  • Change control systems
  • Deviation investigations and root cause analysis
  • cGMP and GDP environments
• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

Job Introduction: We are seeking an experienced Senior Program Manager to lead the delivery and implementation of critical manufacturing and quality systems, including MES, CSV, and EMS, within a fast-paced, high-visibility pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can drive execution across cross-functional teams, proactively manage risk and ambiguity, and ensure projects are delivered on time, with quality, compliance, and strong stakeholder alignment.

Senior Program Manager Responsibilities:

• Lead end-to-end project delivery across MES, CSV, and EMS initiatives
• Manage project scope, schedule, budget, risks, and dependencies
• Drive coordination between IT, Quality, Manufacturing, and external vendors
• Ensure all systems and processes align with GxP and regulatory expectations
• Oversee validation activities, including planning, execution, and documentation
• Facilitate issue resolution and decision-making across stakeholders
• Provide clear and consistent status reporting to leadership
• Support integration efforts across manufacturing and enterprise systems
• Maintain strong governance and change control throughout the project lifecycle

Job Requirements:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field
• 7–12+ years of project management experience in life sciences or regulated industries
• Proven experience delivering MES implementations (e.g., PAS-X, Syncade, Opcenter, etc.)
• Strong background in CSV and validation methodologies (CSA preferred)
• Experience with EMS platforms and integration into manufacturing environments
• Experience with SAP and other Enterprise platforms
• Demonstrated ability to operate in fast-paced, high-pressure environments
• Strong stakeholder management and communication skills
• Experience managing vendors and system integrators
• Familiarity with GxP, 21 CFR Part 11, and data integrity requirements
• Experience supporting greenfield or startup manufacturing environments preferred
• Exposure to biologics, cell and gene therapy, or similar advanced modalities preferred
• PMP or equivalent certification preferred
  

The Capital Project Manager is responsible for the end‑to‑end delivery of capital projects within a GMP-regulated manufacturing environment, from project initiation through commissioning, qualification, and handover. This role requires hands-on construction management capability, strong cross‑functional leadership, and demonstrated experience delivering manufacturing, utilities, and infrastructure projects in compliance with GMP, quality, and regulatory requirements.

The Project Manager is accountable for scope, schedule, cost, quality, safety, and risk, and serves as the primary interface between Engineering, Construction, Quality, Validation, Operations, and external partners.

Capital Project Manager Responsibilities:

Project Leadership & Governance

• Lead capital projects in accordance with enterprise capital governance and phase‑gate requirements 
• Act as single point of accountability for project execution, decision-making, and escalation
• Align project objectives with business needs, operational readiness, and regulatory expectations
• Provide clear and proactive communication to senior leadership and stakeholders

Scope, Cost & Schedule Management

• Define and manage project scope, ensuring alignment with approved business requirements
• Develop, maintain, and control integrated cost and schedule baselines
• Lead change management, trend analysis, and forecast‑at‑completion reporting 
• Ensure timely identification and mitigation of project risks and constraints

Design & Engineering Oversight (GMP Environment)

• Oversee development and approval of URS, Basis of Design, specifications, and drawings
• Ensure GMP design principles are embedded (material/personnel flow, segregation, cleanability)
• Facilitate GMP and constructability design reviews with Quality and Operations
• Ensure documentation supports validation, regulatory inspection, and lifecycle management

Construction Management

• Lead construction planning and execution, including site logistics, sequencing, and safety
• Manage contractors, CM firms, and vendors to ensure efficient and compliant delivery
• Oversee daily/weekly construction progress, field change control, and issue resolution
• Enforce GMP construction controls: segregation, cleanliness, and controlled turnover

Commissioning, Qualification & Validation

• Ensure structured system turnover from construction to commissioning
• Coordinate commissioning activities to support qualification readiness
• Partner with Validation and Quality to support IQ/OQ/PQ execution
• Issue complete, audit‑ready turnover packages to Operations and Quality

Regulatory & Quality Compliance

• Ensure alignment with site change control and regulatory impact assessment requirements
• Support regulatory filings, inspections, and audits as required
• Maintain project documentation in a state of inspection readiness

Closeout & Operations Readiness

• Deliver complete project closeout, including financial, technical, and regulatory documentation
• Support training, SOP updates, asset capitalization, and maintenance handover
• Capture and communicate lessons learned to improve future project delivery

Project Initiation & Planning

• Approved Project Charter and Capital Authorization
• Stakeholder & Communication Plan
• GMP Impact Assessment and Change Control initiation
• Initial Cost Estimate and Level 1–2 Schedule

Design & Pre‑Construction

• User Requirements Specification (URS)
• Basis of Design (BOD)
• GMP Design Review Packages
• Class 3/2 Cost Estimates
• Integrated Master Schedule
• Procurement and long‑lead strategy 

Construction & Execution

• Construction Execution Plan and Site Logistics Plan
• Contractor contracts and bid evaluation documentation
• Weekly and monthly cost/schedule reports
• Change orders and field change documentation
• GMP construction compliance records

Commissioning, Qualification & Validation

• System Turnover Packages
• Commissioning Plans and Reports
• IQ/OQ/PQ support documentation
• Traceability between URS and qualification

Turnover & Closeout

• As‑Built Drawings
• Asset Handover and Operations Readiness Package
• Final Cost Report and Forecast Variance Analysis
• Lessons Learned Report
• In‑Service Date (ISD) approval documentation 

Requirements:

• Bachelor’s degree in Engineering, Construction Management, or related field
• Significant experience delivering capital projects in GMP manufacturing environments
• Strong construction execution and contractor management background
• Demonstrated knowledge of:
  • GMP facility design and construction practices
  • Commissioning and qualification processes
  • Capital cost control, forecasting, and scheduling
• Proven ability to lead cross‑functional teams in regulated environments

Key Competencies:

• Capital project delivery leadership
• GMP and regulatory awareness
• Construction execution and problem solving
• Cost, schedule, and risk management
• Clear executive‑level communication

Systems Engineer Responsibilities:

• Requirements & Traceability: Solicit, manage, and document stakeholder needs and requirements across constituent systems; perform requirements analysis, development, allocation, and management; create and maintain traceability from requirements (including system risk) to system verification and validation; manage requirements flow-down and interface requirements between constituent systems.
• Integration & Verification: Develop and document system test strategies; lead system integration, verification, and validation activities across constituent systems; participate in design reviews and contribute SE deliverables aligned with regulations and standards.
• System Design & Architecture: Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions; apply systems thinking to understand how constituent systems interact within the broader product ecosystem; define and manage system boundaries and interfaces between constituent systems.
• Risk Management: Support system-level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations; drive continuous process improvement focused on SE-related processes and tools; proactively identify and communicate quality issues.

Requirements:

• Bachelor’s degree in an engineering field with 5+ years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities
• Qualified candidates must be legally authorized to be employed in the United States
• Onsite job requirement in Indianapolis, IN

Job Function

The primary areas of focus for this role include technical delivery and business development in the Eastern region of the United States. Verista is structured as a matrixed organization and the delivery operations partners with client services leadership and sales to manage  the overall delivery and client experience collectively. The Validation SME, with Delivery Leader role, is responsible for managing and growing all revenue specific to their respective accounts and region for which they are assigned.

This role provides positive leadership, manages and grows their service offerings by partnering with applicable service owners, sales and client leadership across all their assigned accounts and projects. The Validation SME is a cross functional expert that must work with their Regional Heads and the Executive Leadership Team to develop and ensure quality execution of services, new business opportunities, talent development and packaging of services to optimize profitability.

The successful incumbent will drive the Verista Values and Mission - to be the leading provider of automation and compliance solutions across the entire regulated IT-OT (Information Technology and Operations Technology) Stack. This includes leading strategies and tactics related to ensure:

• Industry Leadership
• Customer Value
• Expansion & Growth
• Collaboration & Scale

The position is to set an example of Verista Culture of hard work, positive attitude, commitment to satisfy the customer, and strong interpersonal skills.

Job Responsibilities                                                                                                                                                                     

• Manage, execute and lead the designated staff on projects they are assigned to ensure customers, sales and service delivery activities meet or exceed customer and company goals and expectations
• As a technical leader in a professional services organization, this role is expected to carry utilization targets on billable projects as a high-level or recognized market SME. Targets are in the 50-75% range and will be specifically defined in alignment with overall Gross Margins targets within your assigned accounts and region. Technical knowledge and ability to connect at all levels are essential to success in this role
• Manage and track to annual goals including Revenue, Margin, Utilization, Employee Retention, & Client Rating
• Develop strategies and tactics to ensure goals are met
• Update monthly goal reports
• The Validation SME – Delivery Leader’s responsibilities as outlined in the corporate RACI document including but not limited to the following areas and activities:
  • Sales and New Engagement Activities in the Delivery Leader Role Capacity
    • Offer and support all lead generation activities, as necessary
    • Responsible for reviewing, assessing and defining all requirements for scope and estimation of contracts
    • New Business Development: The Validation SME – Delivery Leader are responsible for providing the technical depth and supporting relationship development with new logo and existing account sales and client services members during the sales process
  • Project Implementation and Execution as SME
    • Ensure all services projects, initiatives, and processes are in conformance with organization's and customer's established policies and objectives
    • Accountable for all solutioning/delivery methodologies – including the evolution to more managed service offerings utilizing scalable fundamentals related to people, process and technology
    • Focus upon ensuring standards and consistency with each and every employee and client
    • Accountable for accuracy of Salesforce Resource Planner for projects and accounts assigned to you
  • Employee Development and Staffing in Delivery Leader Role Capacity
    • Manages all assigned staff utilization on assigned accounts/projects to optimize revenue, margin and ability to respond to project needs expeditiously
    • Manage team resourcing and forecasting for assigned projects to ensure effective and appropriate staffing levels
    • Clearly and effectively communicate staffing needs (positive or negative) in a timely manner to allow for effective sales
    • Communicate with HR and TA about resource needs including skillset required and timing. Work with TA to recruit talent for the proper mix of Subject Matter Experts and new talent at the proper target utilization level
    • Interview prospective candidates and provide hiring/offer recommendations for executive approval
    • Support the performance review process for Verista FTE employees, providing project related feedback to the employees direct managers for the project you are assigned to
    • Direct management of all contractors on projects at assigned accounts. This includes management of onboarding/offboarding at client sites, as well as management of their time, delivery and client interactions
    • Challenge employees working at assigned accounts to do their best. Have high expectations!
    • Hold employees working at assigned accounts accountable who do not meet expectations and provide feedback appropriately
    • Develop and build a team environment with high morale and positive corporate culture. Provide input on marketing, website, and strategies to facilitate growth

Background Requirements

Education

Bachelor’s degree in a technical (STEM) discipline

Industry Experience

• 15+ years’ engineering experience in GMP regulated environment with direct experience in pharmaceutical or medical device validation
• 5+ years’ professional services and consulting experience
• 5+ years’ experience in professional services business development and customer relations
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:
  • GAMP5
  • Good Documentation Practice (GDP) in pharmaceutical environment
  • ASTM-E2500
  • ISO 14971 – risk management for medical devices
  • ISPE Applied Risk Management for C&Q
  • ISPE Science and Risk Based Approach for the delivery of facilities, systems and equipment
  • ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools
• In depth knowledge of process, manufacturing, and/or packaging equipment validation within Life Sciences or GMP
• CQV and CSV expertise with equipment and associated software systems
• Holistic understanding of process systems including work-processes, optimization methods, risk management, and project management
  • Experience working in a fast paced, high growth, results driven organization
  • Experience in Project Management; managing numerous projects ranging from $50K to in excess of $5MM
  • Prior supervisory experience managing at least 20 people and at least 3-5 direct reports
  • Background in internal and external CSV and CQV validation
  • Sought out for knowledge of best practices in the industry for development of validation standards for pharma/biotech validation and compliance.
  • Prefer validation program management and validation master planning experience

Skills

• Proven experience and aptitude to meet, interact, and present in front of a wide range of customers with varying roles including:
  • C-level executives
  • Project managers and plant engineers
  • Supervisor, operators
• Ability to strategically negotiate with clients and employees in high stress situations to resolve
  • Project and technical issues
  • Funding and change order discussions
  • Employee performance
• Possess a history of strong leadership, deep practical validation knowledge and a proven track record for timely project delivery, project management, cost control, and customer satisfaction.
• Demonstrated ability to provide practical, specific guidance to colleagues regarding the knowledge of appropriate industry guidance and regulatory requirements
• Intermediate to expert skills with WORD, EXCEL and PROJECT Excellent English communication skills (written and verbal)
• Calm and collected leader with the ability to guide a team in stressful client services-oriented projects
• Understanding of laboratory and automation manufacturing and assembly equipment (PLCs, HMIs, PC based controls)
• Understanding of enterprise level systems commonly used in pharma/biotech companies Highly proficient in authoring/editing/executing validation documents for equipment/ facilities/ utilities

Supervisory Requirements

This position will be responsible for project management of employees and contractors working on projects in your portfolio. This is not a Verista internal management position and as such will not assume direct management oversight for FTE employees from a growth and development perspective. This position is responsible for collaboration with Verista employee’s direct managers to provide feedback and performance support. This position is responsible for the direct management of all contractors working on assigned projects per contractual terms. 

Work Environment 

Work is most often performed at the client sites, requiring travel on a regular basis for (1) client and employee check-ins, (2) tech sales support, (3) billable consulting work. The home and office location for this position on the East Coast. This role must reside within a daily commutable distance of this market. Targeting the Boston, NJ, and RTP markets.

Job responsibilities require travel, which varies highly depending upon client and project needs; typical travel is approximately 50%. Business development opportunities and tight project requirements may demand significant hours beyond 40 and hours on the weekend. Average work hours are approximately 45-50 hours/week.

This role must maintain average utilization on billable work. Targets are in the 50-75% range and will be specifically defined in alignment with overall Gross Margins targets within your assigned accounts and region.

The Validation SME is required to sign an Employment agreement document and will be eligible for Senior Leadership Incentive programs.

This position description is designed to represent the majority of the material functions of this position but is not intended to define the position in its entirety.

Project Engineer Responsibilities:

• Support execution of capital and operational projects involving process equipment such as tanks, heat exchangers, and boiler systems
• Read, interpret, and trace P&IDs to support system understanding, troubleshooting, and field execution
• Coordinate and execute line breaks, system tie-ins, and circuit modifications in active manufacturing environments
• Partner with production teams to plan and schedule equipment downtime, minimizing impact to ongoing operations
• Participate in and enforce Lockout/Tagout (LOTO) procedures to ensure safe execution of field work
• Perform hands-on field activities including system walkdowns, troubleshooting, and supporting mechanical installations/modifications
• Assist with process-related tasks including equipment improvements, optimization efforts, and minor design changes
• Collaborate cross-functionally with Maintenance, Operations, EHS, and Quality to ensure projects meet safety and compliance standards
• Support documentation updates (P&IDs, SOPs, change controls) as required
• Track project tasks, timelines, and deliverables; provide updates to stakeholders and escalate risks as needed
• Support contractors and vendors during onsite work, ensuring adherence to site procedures and expectations

Job Requirements:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, or a related technical field
• 2–5 years of experience in pharmaceutical, biotech, or regulated manufacturing environments
• Working knowledge of process equipment such as tanks, heat exchangers, and boilers
• Experience reading and working with P&IDs in a live production setting
• Familiarity with Lockout/Tagout (LOTO) and safe work practices in industrial environments
• Strong mechanical aptitude with a willingness to be hands-on in the field
• Exposure to GMP-regulated environments and working alongside Quality and Compliance teams
• Experience coordinating work during planned shutdowns or production downtime windows
• Experience acting as a project lead or supporting project management activities (scope, schedule, coordination)
• Ability to work occasional off-hours or weekend shifts to support critical project activities
• Ability to be on-site, full-time in Minster, OH

Cleaning Validation Engineer Responsibilities:

• Lead cleaning validation strategy and execution for tech transfer programs
• Perform soil evaluation and ranking to identify worst-case products and residues
• Define worst-case equipment trains/circuits and justification approach
• Develop and support PQ strategy for cleaning validation
• Leverage existing validation data (including prior site data) to support a risk-based approach
• Author and review validation protocols, reports, and risk assessments
• Support cleanability and sample recovery considerations as needed
• Coordinate and help plan/schedule validation activities across multiple workstreams
• Manage deviations, investigations, and CAPAs related to cleaning validation
• Collaborate cross-functionally with Manufacturing, Quality, MS&T, and Engineering
• Ensure compliance with cGMP and regulatory expectations

Requirements:

• Bachelor’s degree in Engineering, Chemistry, or related field
• 5+ years of cleaning validation experience in GMP environment
• Strong experience with:
  • Soil evaluation and worst-case determination
  • Cleaning validation PQ strategy development
  • Risk-based validation approaches leveraging existing data
  • MACO calculations and acceptance limits
• Experience supporting tech transfer or NPI programs
• Ability to manage multiple priorities and workstreams independently

This role requires the ability to be on-site, full-time in Devens, MA.

The Automation Project Manager is responsible for leading automation and IT-focused lifecycle management (LCM) and obsolescence projects across manufacturing and operational environments. This role manages end-of-service-life (EOSL) initiatives ranging from firmware updates to full control system upgrades, ensuring minimal disruption to operations while maintaining compliance with regulatory and quality standards.

Job Responsibilities:

• Lead end-to-end execution of automation lifecycle and obsolescence projects, including PLC, HMI (PanelView), SCADA, and controls system upgrades
• Manage projects ranging from minor firmware updates to full-scale control system replacements, including planning, budgeting, scheduling, and execution
• Coordinate cross-functional teams including Automation, IT, Engineering, Quality, Validation, and Operations
• Oversee vendor and system integration activities for design, development, installation, and commissioning
• Ensure all upgrades align with lifecycle management strategies, cybersecurity standards, and business continuity requirements
• Drive validation activities (as applicable), ensuring compliance with GxP, CSV, and regulatory expectations
• Develop and maintain project documentation including project plans, risk assessments, change controls, and status reports
• Identify and mitigate risks related to system obsolescence, downtime, and integration challenges
• Support shutdown planning, system cutovers, and startup activities to minimize operational impact
• Provide clear communication and reporting to stakeholders on project status, risks, and milestones

Job Requirements:

• Bachelor’s degree in Engineering, Automation, Computer Science, or related technical field
• 5+ years of project management experience in automation, controls, or IT systems within pharma/life sciences manufacturing environments
• Proven experience managing automation upgrade or obsolescence (EOSL) projects
• Strong knowledge of PLCs, HMIs (e.g., PanelView), SCADA systems, and industrial automation infrastructure
• Experience with validation processes (CSV) and regulated environments is highly preferred
• Familiarity with change control, risk management, and lifecycle management practices
• Strong leadership, communication, and stakeholder management skills
• PMP or equivalent project management certification is a plus
• Ability to be on-site, full-time in Mount Vernon, IN

The Facilities / Project Engineer will serve as a Subject Matter Expert (SME) supporting critical utility systems within a regulated pharmaceutical manufacturing environment. This role requires deep mechanical expertise, advanced troubleshooting capability, and a comprehensive understanding of both standard and clean utility systems that directly impact product quality and manufacturing operations. The ideal candidate will operate as the site authority on utilities performance, reliability, and technical problem-solving—driving continuous improvement while ensuring systems operate in a controlled and compliant state.

Job Responsibilities:

• Serve as the site SME for all facility and utility systems, including both plant utilities (HVAC, chilled water, steam, compressed air) and clean utilities (purified water, WFI, clean steam)
• Provide advanced technical support and troubleshooting for complex system issues, including rapid response to critical utility excursions impacting manufacturing
• Lead detailed root cause analyses for system failures, performance deviations, and recurring issues; implement robust, long-term corrective solutions
• Own system performance, reliability, and lifecycle strategy for assigned utilities, including capacity planning, redundancy, and risk mitigation
• Interpret and analyze system data/trends (flows, pressures, temperatures, conductivity, TOC, etc.) to proactively identify risks and optimize performance
• Act as the primary technical interface between Facilities, Manufacturing, Quality, and Engineering to ensure utility systems consistently meet operational and quality requirements
• Support and guide maintenance teams in advanced troubleshooting, repair strategies, and execution of complex mechanical work
• Review and approve technical changes, system modifications, and design updates to ensure alignment with operational needs and system integrity
• Provide technical oversight during installation, startup, and commissioning of new or upgraded utility systems, ensuring proper system functionality and performance
• Develop and enhance preventive and predictive maintenance programs tailored to critical and clean utility systems
• Ensure utilities are designed, operated, and maintained with a clear understanding of their impact on product quality and regulatory expectations
• Support regulatory inspections, audits, and internal reviews as the utilities SME, providing technical justification and system knowledge as required

Job Requirements:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline)
• 5+ years of experience in facilities, utilities, or project engineering within a GMP-regulated industry (pharmaceutical, biotech, or similar)
• Deep technical knowledge of clean utility systems, including purified water (PW), Water for Injection (WFI), clean steam, and associated distribution systems
• Strong mechanical expertise across HVAC systems, boilers, chillers, pumps, heat exchangers, and fluid handling systems
• Proven ability to troubleshoot complex, multi-system issues and drive effective root cause resolution
• Strong understanding of how utility systems impact product quality, process consistency, and regulatory compliance
• Experience working within GMP environments, including interaction with Quality and Manufacturing organizations
• Proficiency in reading and interpreting P&IDs, mechanical drawings, and system schematics
• Familiarity with building management/automation systems (BMS/BAS) and utility monitoring systems
• Strong communication skills with the ability to translate complex technical issues into clear, actionable insights
• Ability to be on-site, full-time, in West Chester, OH

Position Summary:

The LIMS Master Data System Specialist will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at all sites for the GxP LIMS system. This position will be responsible for providing end-user support for all MFG, QC, QA, Supply Chain and analytical groups as well as compliance with global internal policies and procedures. The Sr. specialist is also responsible for LES worksheets design configuration and delivery. The Sr. specialist is responsible for supporting the EMUM program from LIMS perspective. The Sr. Specialist will drive the LIMS master data process from the very beginning to the end including change control management, master data verification, data migration etc. The Specialist will be supporting to increase LIMS data accessibility by writing Jasper Report and testing/installation of Jasper report onto LIMS system.

LIMS Master Data System Specialist Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Work with site leaders to identify, capture and update all master data for each site for GxP operations
• Work with a project team to identify, capture and update all master data f
• Leads QC, QA and MFG departments in the build and/or revision, review and approval of LIMS master data, including but not limited to products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures
• First-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module etc.
• Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data at site facilities\Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS Master Data, including needs for Raw Material, Intermediate, Drug Substance and Finished Product, EM/UM and Stability testing
• Work with the site LIMS Administrator and Business Owner to maintain site and global requirements of LIMS
• Participate in the development and/or revision of Standard Operating Procedures
• Support LIMS System/Process auditing to ensure data is current
• Corporate with training for end users to use the system
• Collect digital platform business requirements, user story and use cases, support user acceptance testing
• Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs
• Responsible for training Jr. specialist with system knowledge and drive through technical difficulty in partnering with the technical lead
• Responsible to master data module maintenance and perform system master data related impact assessment and taking change actions
• Build instruments and consumable including critical reagents master data in LIMS system

Requirements:

• Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent. Combined degrees and/or experience in fields of biology, data analysis, Statistics and data science is preferred
• Typically requires 2- 4 years relevant experience in the Life Sciences, or the equivalent combination of education and experience
• Familiarity with cell and gene therapy methodologies such as Cell Viability, Flow cytometry and other cell functional assays
• Knowledge of LabVantage system master data and system usage functionality, requires at least 3 years of experience
• Knowledge of regulated systems – general level of understanding of systems validation
• Capable and comfortable multi-tasking between concurrent projects
• Experience of GxP laboratory and Manufacturing process, and non-GxP research laboratory analytical development and product processes development
• Must demonstrate ability to work in a team environment and willingness to assume additional or new responsibilities readily
• Must detail oriented pay close attention and notice minor details
• Effective communication skills, both verbal and written. Knowledge of regulated systems – general level of understanding of systems validation
• Skills of Master Data management in LIMS Systems, together with Data Analysis/Data Management
• Capable and comfortable multi-tasking between concurrent projects
• Onsite job requirement in Boston, MA

Validation/CQV Engineer Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment

Requirements:

• Bachelor’s Degree or equivalent required
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Onsite work requirements in Indianapolis, IN

Facilities Project Manager Job Responsibilities:

• Lead full lifecycle capital projects with a focus on pharmaceutical utilities and facilities systems (HVAC, clean utilities, WFI, clean steam), ensuring delivery on scope, schedule, and budget
• Manage concurrent engineering projects including facility upgrades, infrastructure improvements, packaging, and inspection systems
• Provide technical leadership for GMP-regulated facility and utility projects, ensuring compliance with CQV and validation requirements
• Develop and control capital budgets and forecasts, track spend, and manage financial performance across projects
• Oversee construction activities and contractor execution (preferred), including bid evaluation, field coordination, and safety compliance
• Ensure adherence to project governance, design reviews, change control, and validation documentation (IQ/OQ/PQ)
• Collaborate cross-functionally with Facilities, Manufacturing, Quality, Validation, and EHS to support site readiness and operational reliability
• Manage external vendors, contractors, and engineering firms to ensure quality, safety, and timely project delivery

Job Requirements:

• Bachelor’s degree in Engineering required; strong project scheduling, budgeting, and leadership skills expected
• 7–10+ years of experience in pharmaceutical/biotech environments with a focus on utilities, facilities, and capital projects
• Advanced proficiency with Microsoft Project or similar tools for complex project scheduling
• Strong experience in capital budgeting, forecasting, and cost control, particularly for facility and construction projects
• Strong knowledge of GMP requirements and equipment qualification
• Deep understanding of pharmaceutical utility systems (HVAC, clean rooms, WFI, clean steam, process gases, building management systems)
• Experience with facility design, equipment layout, and infrastructure integration
• Knowledge of GMP requirements, equipment qualification (IQ/OQ/PQ), and validation lifecycle
• 100% on-site presence required (Newark, DE)
  

We are seeking a CQV Engineer with hands-on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Solution Preparation Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP regulations and internal quality procedures.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Solution Preparation Process Support

• Provide technical support for solution preparation unit operations, including systems such as:

  • Buffer preparation systems

  • Media preparation systems

  • Solution preparation tanks and mixing systems

  • Single-use mixing systems

  • Transfer and hold systems

• Support equipment startup and operational readiness for solution preparation processes.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.

• Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Assist with deviation investigations, change control processes, and documentation updates.

• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.

• Maintain data integrity, traceability, and compliance within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with solution preparation, buffer prep, or media prep systems

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)

• Ability to work independently while coordinating with cross-functional teams

• Strong technical documentation and communication skills

• Experience using digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with single-use systems and biologics manufacturing processes

• Experience working within biologics or cell culture manufacturing facilities

• Onsite job requirement in Apex, NC

We are seeking a CQV Engineer with hands-on experience supporting Clean-in-Place (CIP) systems within biopharmaceutical manufacturing environments. This role will focus on commissioning, qualification, and validation activities for CIP systems and related process equipment, ensuring systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This role requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution throughout the lifecycle of the system.

CIP (Clean-in-Place) CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for CIP systems and related process equipment.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP requirements and regulatory expectations.

• Participate in system impact assessments, risk assessments, and validation planning activities.

CIP System Support

• Provide technical support for Clean-in-Place (CIP) systems and automated cleaning processes used in biopharmaceutical manufacturing.

• Support qualification of CIP skids, automated cleaning cycles, and associated process equipment.

• Verify cleaning cycle parameters including flow rates, temperatures, chemical concentrations, and cycle timing.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new CIP equipment and systems.

• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.

• Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Collaboration

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to ensure successful project execution.

• Assist with deviation investigations, change control processes, and documentation updates.

• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.

• Ensure documentation integrity, traceability, and compliance within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with CIP systems and automated cleaning processes

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)

• Ability to work independently while coordinating with cross-functional project teams

• Strong technical documentation and communication skills

• Experience using digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with automated process systems and PLC-based equipment

• Experience in biologics or large-scale biopharmaceutical manufacturing environments

• Onsite job requirement in Apex, NC

We are seeking a CQV Engineer with hands-on experience in downstream bioprocessing systems to support commissioning, qualification, and validation activities within biopharmaceutical manufacturing environments. This role will focus on downstream unit operations and purification equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working with digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Downstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for downstream bioprocess equipment and systems.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP, regulatory standards, and internal quality procedures.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Downstream Bioprocess Support

• Provide technical support for downstream purification unit operations, including systems such as:

  • Chromatography systems

  • Tangential Flow Filtration (TFF) / Ultrafiltration systems

  • Depth filtration systems

  • Viral filtration systems

  • Buffer preparation and hold systems

• Support equipment startup and operational readiness for downstream process systems.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Startup Activities

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new downstream process equipment.

• Coordinate with equipment vendors and system integrators to ensure proper installation and functionality.

• Participate in equipment startup, commissioning, and performance verification activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Support deviation investigations, change controls, and documentation updates as required.

• Ensure CQV activities are completed in accordance with project schedules and milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to author, manage, and execute validation documentation.

• Maintain documentation integrity and traceability within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

• Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with downstream bioprocess equipment and purification systems

• Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work independently while collaborating with cross-functional teams

• Strong documentation, organizational, and communication skills

• Experience with digital validation systems such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Experience in biologics manufacturing or monoclonal antibody production environments

• Onsite job requirement in Holly Springs, NC

We are seeking a CQV Engineer with hands-on experience in upstream bioprocessing systems to support commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will focus on upstream unit operations and process equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, coordinating commissioning activities, supporting vendor testing, and ensuring systems achieve operational readiness. Experience with digital validation platforms such as Kneat is highly desirable.

This position requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Upstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for upstream bioprocess equipment and systems.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation aligns with cGMP requirements and regulatory expectations.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Upstream Bioprocess Support

• Provide technical support for upstream bioprocess unit operations, including systems such as:

  • Bioreactors / fermenters

  • Media and buffer preparation systems

  • Cell culture support equipment

  • Filtration and associated upstream utilities

• Support equipment startup and operational readiness for upstream process systems.

• Collaborate with engineering and operations teams to resolve technical issues during commissioning and qualification.

Vendor & Startup Activities

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

• Coordinate with equipment vendors and integrators to ensure proper system installation and functionality.

• Participate in equipment startup, troubleshooting, and performance verification.

Cross-Functional Coordination

• Work closely with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Ensure commissioning and validation activities remain aligned with project timelines and milestones.

• Assist with deviation resolution, change control, and documentation updates as required.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop and execute validation documentation.

• Ensure documentation integrity, traceability, and compliance within digital validation systems

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical field

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with upstream bioprocess equipment and systems

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work cross-functionally with engineering, automation, vendors, and quality teams

• Strong communication, documentation, and organizational skills

• Experience with digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Prior experience in biologics or cell culture manufacturing environments

• Onsite job requirement in Holly Springs, NC

Lead Process Engineer Responsibilities:

• Lead and execute Design of Experiments (DOE) studies to evaluate and optimize pharmaceutical manufacturing and packaging processes
• Provide technical leadership for process improvement initiatives, focusing on efficiency, reliability, and product quality
• Support and optimize liquid/gel filling and bottle/tube packaging operations within pharmaceutical manufacturing environments
• Conduct root cause investigations for process deviations or performance issues and implement sustainable corrective actions
• Collaborate with cross-functional teams including manufacturing, quality, and engineering to support process development and improvement efforts
• Serve as a client-facing technical expert, working directly on-site with customers and stakeholders to address process challenges
• Document process studies, experimental results, and improvement initiatives in accordance with industry and company standards

Job Requirements:

• Bachelor’s or Master’s degree in Chemical Engineering
• 5–10+ years of experience in the pharmaceutical industry supporting manufacturing or process engineering
• Minimum 5 years of hands-on experience designing and executing DOE (Design of Experiments) studies
• Demonstrated experience supporting liquid/gel filling and bottle/tube packaging processes
• Strong analytical and problem-solving skills with experience performing root cause analysis and implementing process improvements
• Ability to work on-site 75%+ of the time

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

Complaint Investigator / Quality Specialist Responsibilities:

• Review and investigate complaint information provided
• Perform visual/functional assessment as required
• Utilize TrackWise to record and document Complaint History
• Research Deviation, Batch Record Review, Design History File/FMEA Review, Product Safety Assessment and Product Impact Evaluation background information pertaining to complaint
• Contact data stewards in order to gain more insight into complaint and gather data as needed
• Utilize Root Cause Investigation Summary and CAPA Overview as necessary to inform investigation
• Author Templates for basic complaints and complex complaints
• Utilize Templates to expedite the investigation write-up process for future complaint investigations

Requirements:

• Demonstrated capability to deliver on the Quality Specialist Responsibilities
• Capacity to make independent sound decisions and independently manage priorities
• Demonstrated ability to generate high-quality project deliverables independently by required due dates
• Capacity to identify issues and proactively elevate to the project lead
• Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
• Minimum 2 years of role relevant experience

Job Summary:

We are seeking a Risk Management Project Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 1-3 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint
• Onsite job requirement in Indianapolis, IN

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Senior Automation Engineer Responsibilities:

• Automation Engineer strong in IT/IT-centric systems to help with troubleshooting, detecting issues
• Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
• General Change management
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
• Running test scripts and documenting results.
• Adherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team.
• Design and PLC programming (configuration of PLC program) on standard equipment/products
• Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations
• Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams
• Contribute to the completion of projects, manage own time on agreed targets, develop plans for own projects and leads small project teams
• Monitor, generate and complete the periodic review, validation master plan for the automation engineering program
• Demonstrate good planning, organizing, time management and team participation skills
• Responsible for routine and preventive maintenance work, ensure all the equipment and facilities work safely, efficiently and reliably
• Generate and develop standard operating procedures and system support
• Analyze operational process problems and recommend appropriate corrective and preventative actions
• Manage change control authoring and execution
• Participate in the site and network wide teams to provide cybersecurity alignment and direction
• Provide 24x7x365 support of automation systems and perform automation activities for capital and non-capital projects
• Modify moderately complex to highly complex control logic that requires a degree of scientific and/or manufacturing process expertise
• Clearly communicate progress and issues to peers

Requirements:

• Must have 3-5 years of industrial experience as an Automation Engineer
• Experience in creating SQL databases
• Understanding domain authentication
• Experience in working with IT to schedule implementations
• Able to complete software installs and/or updates
• Creation of databases
• Experience in upgrading system requirements for servers
• Understanding of Citrix application
• GMP and Good Documentation Practice knowledge
• Position requires onsite work in Indianapolis, IN
• Responsible for installing, maintaining, and troubleshooting automated utility, processing, filling, inspection, and packaging equipment
• Generate user requirement specifications for control systems
• Able to make minor modifications to code and HMI graphics for smaller changes
• Must be able to read logic and perform programming as well as update control system documentation
• Contribute technical content to validation protocols on automation systems and perform execution of protocols

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 3-5 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Overview:

We are seeking a highly organized and detail-oriented Project Coordinator to support capital expenditure (CapEx) projects within a facilities and engineering environment. This individual will play a critical role in project controls, financial coordination, and procurement activities, ensuring projects are executed efficiently, compliantly, and in alignment with organizational standards.

The ideal candidate will bring strong experience in project coordination, financial tracking, and cross-functional collaboration, with the ability to manage multiple priorities in a fast-paced, regulated setting.

Project Coordinator Responsibilities:

• Support project controls processes, procedures, and systems for capital expenditure projects
• Maintain and communicate Facilities Notices (will be trained, no prior experience is required)
• Maintain and communicate Fire System Scheduler (will be trained, no prior experience is required)
• Process purchase requisitions and change orders
• Perform financial cross check on all requisitions for quality and CPC contracts processing standards
• Perform self-authoring of contracts for all requisitions and change orders
• Monitor purchase orders and identify potential issues and risks
• Prepare and present requisition status reports to project stakeholders.
• Identify opportunities to improve project controls processes and systems and make recommendations
• Ensure compliance with relevant regulations and industry standards
• Actively participate and support the contracts processing team
• Collaborate daily with the Legal, Procurement, and offshore database teams
• Comfortable in High Volume Job processing

Requirements:

• Bachelor’s degree in Business, Engineering, Construction Management, or related field preferred
• 2–5+ years of experience in project coordination, project controls, or capital projects support
• Experience with purchase requisitions, purchase orders, and financial tracking/reporting
• Strong proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with ERP systems is a plus
• Familiarity with regulated environments (pharmaceutical, biotech, or manufacturing) is preferred
• Onsite job requirement in Novato, CA on a hybrid basis

Senior Project Manager – Facilities & Utilities

Position Overview

The Senior Project Manager provides high-level leadership and technical oversight for complex facility modifications, expansions, and new facility construction projects within pharmaceutical environments. As a Verista consultant, this role operates as a trusted advisor and project delivery lead across engineering, operations, construction, and validation groups. The Senior PM is accountable for scope alignment, schedule performance, cost control, vendor management, and field execution from project initiation through turnover. Experience with Primavera P6 is strongly preferred. CQV experience is preferable but not required.

Key Responsibilities

Client-Facing Leadership

• Act as the primary Verista representative supporting client engineering and capital project teams.
• Advise on project strategy, risk posture, technical decisions, and resource planning.
• Lead cross-functional alignment across engineering, operations, maintenance, quality, EHS, construction, and CQV.
• Elevate project performance expectations and establish strong communication channels across all stakeholders.

Project Execution – Facilities, Utilities & Capital Delivery

• Lead major facility modification, expansion, infrastructure upgrade, and new facility build projects.
• Develop integrated schedules using Primavera P6 (preferred) or equivalent; manage critical path and milestones such as Microsoft Projects.
• Build and oversee capex project budgets, cost models, forecasts, cash flow tracking, and variance reporting.
• Drive execution readiness including design reviews, constructability walks, permitting, and pre-mobilization planning.
• Coordinate shutdowns, tie-ins, outages, and sequencing to prevent operational impact.

Construction Oversight & Field Coordination

• Conduct site walks as needed during construction; construction teams and site EHS own all EHS responsibilities.
• Oversee general contractors and trades to ensure compliance with design intent, specifications, cGMP standards, and schedule.
• Review RFIs, submittals, redlines, shop drawings, purchase orders, and change orders.
• Hold construction partners accountable to quality, documentation, progress tracking, and installation readiness.
• Ensure turnover of construction packages, redlines, and field documentation required for startup and CQV.

Technical Expertise – Facility & Utility Systems

• Support the design and installation of building infrastructure, cleanrooms, HVAC systems, architectural builds, and process areas.
• Oversee clean utilities (WFI, clean steam, CIP/SIP, compressed air, nitrogen), black utilities, and core MEP systems.
• Ensure technical decisions prioritize long-term reliability, maintainability, and GMP compliance.
• Coordinate with engineering partners on URS/FRS alignment, equipment sizing, utility loads, and design changes.

Vendor, OEM & Trades Management

• Support vendor sourcing, bid evaluations, negotiation, and development of scopes of work.
• Coordinate FAT/SAT activities, equipment delivery, installation planning, and readiness checks.
• Manage OEMs, engineering firms, general contractors, and specialty trades to maintain alignment with project requirements.

Risk, Compliance & Documentation

• Maintain detailed risk registers and drive proactive mitigation for cost, schedule, technical, and supply-chain risks.
• Support client quality teams in assessing change control impacts and regulatory pathway alignment.
• Ensure complete engineering, construction, and CQV turnover documentation for startup and audit readiness.

Required Qualifications

• Bachelor’s degree in Engineering, Construction Management, or related technical discipline.
• 10+ years of project management experience in pharmaceutical or regulated environments.
• Demonstrated leadership in capital projects: renovations, expansions, infrastructure upgrades, and new facility builds.
• Strong technical understanding of utilities, HVAC, cleanrooms, MEP systems, and facility infrastructure.
• Proven experience managing contractors, trades, engineering firms, and OEMs.
• Expertise in schedule development and analysis; Primavera P6 strongly preferred.
• Strong financial acumen including capex planning, forecasting, and cost control.
• Excellent communication, documentation, and stakeholder management skills.

Preferred Qualifications

• CQV experience (preferred but not required).
• Knowledge of GMP, FDA/EMA expectations, and engineering documentation practices.
• Prior consulting experience with direct client‑facing responsibilities.
• Experience supporting FAT/SAT, startup readiness, and facility turnover.

Work Expectations

• On-site presence required at client facilities to support construction, execution, and coordination.
• Travel required for FATs, vendor visits, multi‑site support, and project reviews.
• Ability to independently manage workstreams, priorities, and communication in a consulting environment.

Join Our Team: Validation Engineers Wanted in Bloomington, IN!

Are you a skilled Validation Engineer with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant Bloomington, IN area!

Who We’re Looking For:

• Experience: 3+ years in validation engineering within pharmaceuticals or biotech.

• Skills: Expertise in equipment qualification, Delta V, Upstream/Downstream process validation, GMP compliance, CIP/SIP, HVAC, or Utilities.

• Location: Based in or willing to relocate to Bloomington, IN.

• Passion: Dedicated to delivering high-quality solutions that ensure patient safety and regulatory compliance.

What We Offer:

• Exciting projects with leading pharmaceutical companies.

• Competitive compensation and benefits based on proven experience.

• Opportunities for professional growth and development.

• A collaborative, innovative work environment in the heart of the Research Triangle.

Ready to make an impact? Apply for more details. Let’s shape the future of pharmaceuticals together!

#PharmaJobs #ValidationEngineer #Bloomington #Hiring #ExpertsDeliveringSolutions

Responsibilities:

Entry level CQV Engineer position in the Pharma industry. Client will train the resource on Deviation Investigation.

Requirements

• Deviation investigation remediation experience is a plus but is not necessary.
• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.).
• 0-3 years experience. Some Pharma experience preferred but not absolutely required. New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities.
• Experience with and tolerance for high levels of challenge and change.

CQV Engineer Responsibilities:

• New or recent graduates are encouraged to apply
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Understanding validation documents, URS, IQ, OQ, PQ

Requirements:

• Must be willing to work onsite in Portland, ME.
• Bachelor’s or equivalent STEM degree required (Biomedical Engineer, Chemical Engineer, etc.)
• Demonstrated experience in leading CQV activities specific to Process Equipment (internship experience preferred)
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

CQV Engineer Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Understanding validation documents, URS, IQ, OQ, PQ

Requirements

• Must be willing to work onsite in Columbus, OH
• Bachelor’s Degree or equivalent required (STEM degree highly preferred)
• Demonstrated experience in leading CQV activities specific to Process Equipment
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

CQV/Process Engineer Responsibilities:

CQV Engineers execute commissioning, qualification and validation projects involving new 
or modified systems/equipment, processes, procedures, products, facilities, and utilities. In this role, validation 
engineers support the validation and change lifecycles for client’s systems in pharmaceutical and medical device 
manufacturing, laboratory, IT, and packaging operations to meet timeline, budget, quality, regulatory compliance, 
and client expectations.

Process Engineers support conceptual and detailed design, support in process scale-up, product development, process validation, and implementation of operational improvements that resolve manufacturing process investigations in pharmaceutical manufacturing environments. In this role, you may work in concert with the client or as part of a Verista team tasked in determining the root cause of manufacturing investigations or in designing/executing experiments and evaluating data in support of improvement and investigations. Additionally, engineers write technical reports in support of manufacturing process changes, optimizations, and regulatory filings (where required).

This is an entry level role. College graduates are encouraged to apply. We are looking for smart, hardworking team players to grow professionally into this role at our client site in Kalamazoo, MI.

Requirements

• Bachelor’s degree in chemical, biomedical/biochemical engineering, biological/chemical sciences or equivalent required
• Must live in or relocate to the Kalamazoo MI area
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Excellent organizational and time management skills
• Strong attention to detail
• Possess excellent interpersonal, verbal, and written communication skills.
• GxP and Good Documentation Practice training (may be completed at onboarding)
• Process training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change

Join Our Team: Automation Engineers Wanted in Raleigh/Durham, NC!

Are you a skilled Automation Engineer with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant Raleigh/Durham, NC area!

Who We’re Looking For:

• Experience: 3+ years in automation engineering within pharmaceuticals or biotech.
• Skills: DeltaV for DCS systems: programming, designing, lifecycle management, commissioning, and troubleshooting. Rockwell/Allen‑Bradley PLCs and FactoryTalk SCADA: programming, configuration, integration, and operational support in GMP environments. Siemens PLCs & Building Automation Systems such as Desigo CC: design, installation, validation, and network deployments for utilities/building controls.
• Location: Based in or willing to relocate to Raleigh/Durham, NC.
• Passion: Dedicated to delivering high-quality solutions that ensure patient safety and regulatory compliance.

What We Offer:

• Exciting projects with leading pharmaceutical companies.
• Competitive compensation and benefits based on proven experience.
• Opportunities for professional growth and development.
• A collaborative, innovative work environment in the heart of the Research Triangle.

Ready to make an impact? Apply for more details. Let’s shape the future of pharmaceuticals together!

#PharmaJobs #AutomationEngineer #RaleighDurham #Hiring #ExpertsDeliveringSolutions

Join Our Team: Validation Engineers Wanted in Raleigh/Durham, NC!

Are you a skilled Validation Engineer with a passion for ensuring quality in the pharmaceutical industry?  Highly experienced individuals encouraged to apply. Verista is actively seeking talented professionals to join our team in the vibrant Raleigh/Durham, NC area!

Who We’re Looking For:

• Experience: 3+ years in validation engineering within pharmaceuticals or biotech.

• Skills: Expertise in equipment qualification, Delta V, Upstream/Downstream process validation, GMP compliance, CIP/SIP, HVAC, or Utilities.

• Location: Based in or willing to relocate to Raleigh/Durham, NC.

• Passion: Dedicated to delivering high-quality solutions that ensure patient safety and regulatory compliance.

What We Offer:

• Exciting projects with leading pharmaceutical companies.

• Competitive compensation and benefits based on proven experience.

• Opportunities for professional growth and development.

• A collaborative, innovative work environment in the heart of the Research Triangle.

Ready to make an impact? Apply for more details. Let’s shape the future of pharmaceuticals together!

#PharmaJobs #ValidationEngineer #RaleighDurham #Hiring #ExpertsDeliveringSolutions

Join Our Team: Project Managers Wanted in Raleigh/Durham, NC!

Are you a skilled Project Manager with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant Raleigh/Durham, NC area!

Who We’re Looking For:

• Experience: 3+ years in project management within pharmaceuticals or biotech.
• Skills: Ability to lead the plan, execute, and deliver complex projects. Manage project timelines, milestones, budgets, resources, and risk mitigation plans. Ensure compliance with regulatory requirements (GxP, FDA, EMA) and internal quality systems.
• Location: Based in or willing to relocate to Raleigh/Durham, NC.
• Passion: Dedicated to delivering high-quality solutions that ensure patient safety and regulatory compliance.

What We Offer:

• Exciting projects with leading pharmaceutical companies.
• Competitive compensation and benefits based on proven experience.
• Opportunities for professional growth and development.
• A collaborative, innovative work environment in the heart of the Research Triangle.

Ready to make an impact? Apply for more details. Let’s shape the future of pharmaceuticals together!

#PharmaJobs #Project Manager #RaleighDurham #Hiring #ExpertsDeliveringSolutions

Join Our Team: QA Specialists Wanted in Raleigh/Durham, NC!

Are you a skilled QA Specialist with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant Raleigh/Durham, NC area!

Who We’re Looking For:

• Experience: 3+ years in quality assurance within pharmaceuticals or biotech.
• Skills: Overseeing compliance with cGMP, GDP, and other regulatory standards for facilities, equipment, processes, and documentation. Managing deviations, CAPA (corrective and preventive actions), change control, validations, and audits. Ensuring production/testing records are accurate and complete.
• Location: Based in or willing to relocate to Raleigh/Durham, NC.
• Passion: Dedicated to delivering high-quality solutions that ensure patient safety and regulatory compliance.

What We Offer:

• Exciting projects with leading pharmaceutical companies.
• Competitive compensation and benefits based on proven experience.
• Opportunities for professional growth and development.
• A collaborative, innovative work environment in the heart of the Research Triangle.

Ready to make an impact? Apply for more details. Let’s shape the future of pharmaceuticals together!

#PharmaJobs #QA #QualityAssurace #RaleighDurham #Hiring #ExpertsDeliveringSolutions