Lead Validation Engineer Responsibilities:

• Lead second shift CQV execution activities across multiple systems and workstreams
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines
• Interface with QA, Engineering, and Operations to resolve issues in real time
• Oversee execution of IQ/OQ protocols and operational verification activities
• Support and review: 
  • Drawing walkdowns
  • Equipment and component verification
  • Materials of Construction (MOC) and weld verification
• Provide oversight for temperature mapping and validation activities
• Support SIP/CIP and related cycle development activities as needed
• Ensure all documentation meets GMP/GDP and audit-ready standards
• Drive deviation identification, escalation, and resolution

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 8+ years of CQV/validation experience in pharma or biotech
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
• Proven experience leading validation teams or shift-based execution efforts
• Strong GMP/GDP knowledge
• Experience with eVal (required), ValGenesis a plus
• Experience with temperature mapping (Ellab a plus)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

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

Senior Validation Engineer Responsibilities:

• Execute IQ/OQ protocols and support operational verification activities
• Perform Drawing walkdowns (P&IDs, system verification)
• Perform Equipment/component verification
• Perform MOC and weld verification
• Support temperature mapping activities using data loggers and validation tools
• Assist with SIP/CIP execution and cycle development activities
• Identify and document deviations and support investigations
• Ensure accurate and complete documentation in compliance with GMP/GDP standards
• Work collaboratively with engineering, QA, and operations teams

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 3–8 years of CQV/validation experience
• Hands-on experience executing validation for process equipment
• Strong GMP/GDP fundamentals
• Experience with IQ/OQ execution and field verification activities
• Experience with eVal (required), ValGenesis a plus
• Exposure to temperature mapping (Ellab a plus)
• Experience with bioprocess equipment preferred (bioreactors, filtration, chromatography, UF)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

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

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

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.

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.

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