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

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

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)
  

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.

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: 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!

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