CQV Engineer

CQV Engineer

Overview

An established engineering and consulting organisation supporting the life sciences industry is seeking a CQV / Validation Engineer or Lead Validation Engineer to join its growing team. The organisation partners with pharmaceutical, biotechnology, medical device, and advanced manufacturing companies to deliver technical solutions that support innovation, regulatory compliance, and operational excellence.

This position offers the opportunity to contribute to complex manufacturing and capital projects while supporting the commissioning, qualification, and validation of critical systems and equipment within GMP-regulated environments.

Key Responsibilities

Commissioning, Qualification & Validation (CQV)

• Execute commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and process systems.
• Author, review, and execute validationlifecycle documentation, including:
  • Commissioning Protocols
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary Reports
  • Traceability Matrices
  • Risk Assessments
• Support startup and operational readiness activities for new production equipment and manufacturing systems.
• Conduct field verification activities, system walkdowns, and documentation reviews to ensure installations meet design and operational requirements.
• Coordinate testing activities with engineering, manufacturing, quality, and vendor teams.
• Verify that systems and equipment operate in accordance with GMP and regulatory requirements.

Manufacturing & Technical Support

• Support qualification activities for production equipment used within pharmaceutical manufacturing operations.
• Troubleshoot qualification and validation issues encountered during equipment startup, commissioning, and testing.
• Review engineering documentation including P&IDs, specifications, equipment drawings, and vendor documentation.
• Assist with the identification, investigation, and resolution of deviations, discrepancies, and validation-related issues.
• Ensure manufacturing systems meet regulatory, quality, and operational standards.

Compliance & Documentation

• Execute validation activities in accordance with current GMP requirements and internal quality procedures.
• Maintain clear, accurate, and compliant validation documentation throughout the project lifecycle.
• Support change controls, CAPAs, deviations, risk assessments, and validation impact assessments.
• Participate in regulatory audits and inspections, providing validation subject matter expertise when required.

Additional Responsibilities - Lead Validation Engineer

• Provide technical leadership and mentorship to validation engineers and project team members.
• Coordinate validation schedules, deliverables, and execution activities across multiple systems and projects.
• Communicate project status, risks, and resource requirements to project leadership and stakeholders.
• Review and approve validation documentation developed by junior team members.
• Lead efforts to resolve complex qualification, startup, and compliance challenges.

Requirements

Validation Engineer

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of 3 years' experience in CQV, validation, commissioning, or qualification activities.
• Experience working within GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environments.
• Strong understanding of validation lifecycle methodologies and documentation requirements.
• Proven experience authoring and executing IQ, OQ, and PQ protocols.
• Ability to work onsite in Devens, MA

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of 5 years' experience in CQV, validation, pharmaceutical manufacturing, or related disciplines.
• Demonstrated experience leading validation projects and supporting cross-functional teams.
• Strong technical knowledge of equipment qualification and validation lifecycle management.

Preferred Qualifications

• Experience supporting startup activities for new manufacturing lines, facilities, or major capital projects.
• Background within pharmaceutical manufacturing, sterile processing, biologics, or contract manufacturing environments.
• Knowledge of FDA, EU GMP, ISPE, and GAMP guidance and regulations.
• Experience managing deviations, change controls, CAPAs, and risk assessments.
• Strong technical writing and documentation skills.
• Excellent communication and stakeholder management abilities.

Key Skills

• Commissioning, Qualification & Validation (CQV)
• Equipment Qualification & Validation
• GMP Compliance
• IQ / OQ / PQ Protocol Development & Execution
• Manufacturing Systems Validation
• Technical Writing & Documentation
• Risk Assessments
• Deviation & CAPA Management
• Change Control
• Cross-Functional Collaboration
• Startup & Operational Readiness
• Problem Solving & Troubleshooting
• Pharmaceutical Manufacturing Operations

What's on Offer

• Opportunity to work on cutting-edge pharmaceutical and life sciences projects.
• Exposure to large-scale manufacturing facility expansions and startup initiatives.
• Collaborative and technically focused team environment.
• Career progression opportunities within a growing organisation.
• Competitive compensation and comprehensive benefits package.

Location: Devens, MA (Onsite)
Industry: Pharmaceutical / Biotechnology / Life Sciences
Employment Type: Full-Time