Senior CQV Engineer/Manager

Position Overview

We are seeking an experienced CQV (Commissioning, Qualification & Validation) professional to support and lead validation activities within highly regulated pharmaceutical, biotechnology, and life sciences environments. This role will be responsible for ensuring GMP compliance across facilities, utilities, equipment, manufacturing processes, and computerized systems while driving validation strategies and project execution.

Key Responsibilities

• Lead and support Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, equipment, laboratory systems, and manufacturing processes.
• Develop and execute Validation Master Plans (VMPs), risk assessments, traceability matrices, and validation protocols.
• Author, review, and approve IQ/OQ/PQ protocols and validation summary reports.
• Capture commissioning and qualification activities for cleanrooms, HVAC systems, water systems (PW/WFI), clean steam, compressed gases, and manufacturing equipment.
• Support Factory Acceptance Tests (FAT), System Acceptance Tests (SAT), startup, and operational readiness activities.
• Manage deviations, investigations, CAPAs, and change controls.
• Ensure compliance with FDA, EMA, MHRA, GAMP 5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Automation, Regulatory Affairs, and Validation teams.
• Support regulatory inspections, audits, and remediation activities.
• Provide leadership and mentoring to validation engineers and CQV team members.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
• 10+ years of CQV / Validation experience within pharmaceutical, biotechnology, medical device, or life sciences industries.
• Strong experience with GMP, cGMP, and regulatory compliance requirements.
• Extensive hands-on experience with:
• Commissioning, Qualification & Validation (CQV)
• IQ / OQ / PQ Execution
• Validation Master Plans (VMP)
• Risk Assessments
• Traceability Matrix Development
• Deviation, CAPA, and Change Control Management
• GMP Documentation and Compliance

• Cleanroom Qualification
• HVAC Qualification
• Water Systems (PW/WFI)
• Clean Steam Systems
• Compressed Air/Gas Systems
• Manufacturing Equipment Qualification
• Packaging Equipment Validation
• Laboratory Equipment Qualification
• Process Validation
• Computer System Validation (CSV)
• Supporting one or more of the following systems:
• MES
• LIMS
• Empower
• TrackWise
• Veeva
• SAP
• DeltaV
• SCADA Systems
• Laboratory Informatics Systems

Technical Experience Required

• Pharmaceutical or Biotechnology Manufacturing
• Cell & Gene Therapy
• Biologics Manufacturing
• Vaccine Manufacturing
• Greenfield Facility Startups
• Large Capital Projects
• Regulatory Inspection Readiness

Preferred Experience

• Pharmaceutical or Biotechnology Manufacturing
• Cell & Gene Therapy
• Biologics Manufacturing
• Vaccine Manufacturing
• Greenfield Facility Startups
• Large Capital Projects
• Regulatory Inspection Readiness

Preferred Certifications

• PMP
• CQV / Validation Certifications
• ASQ Certifications (CQE/CQA)
• ISPE Training
• Lean Six Sigma Green Belt or Black Belt

Must-Have Skills

• CQV (Commissioning, Qualification & Validation)
• GMP / cGMP Compliance
• IQ/OQ/PQ
• Validation Master Plans (VMP)
• Risk Assessments
• Traceability Matrix
• CAPA & Deviation Management
• Cleanroom / HVAC Qualification
• Utilities Qualification (PW/WFI/Clean Steam)
• Computer System Validation (CSV)
• FDA / EMA / GAMP 5 Compliance