CQV Engineer

We are seeking a highly skilled and motivated CQV Engineer to lead and execute commissioning qualification, and validation (CQV) activities across our GMP manufacturing and laboratory environment. In this role you will ensure that equipment, facilities, utilities, automation systems and supporting infrastructure are designed, installed, tested, and maintained in compliance with cGMP requirements and regulatory environment.

You will play a key role in supporting capital projects, facility expansions, process improvements, and equipment implementation initiatives. This role collaborates cross‑functionally with Engineering, Manufacturing, Quality, Automation, Process Development, and external vendors to ensure successful project execution and operational readiness.

• Lead commission, qualification, and validation activities for GMP equipment, utilities, facilities, automation systems, and infrastructure.
• Develop and execute CQV documentation including Validation Plans, Risk Assessments, Commissioning Protocols, IQ/OQ/PQ protocols, Traceability Matrices, and Final reports.
• Author, review, and approve technical documents, including SOP's, change controls, deviations, CAPAs, and validation lifecycle documentation.
• Support implementation and qualification of manufacturing equipment, clean utilities, HVAC systems, laboratory equipment, and computerized systems.
• Coordinate startup, shakedown, commissioning, and qualification activities to support operational readiness and project timelines.
• Ensure all validation activities comply with cGMP regulations, data integrity standards and company procedures.
• Partner cross‑functionally with Quality Assurance, Manufacturing, Engineering, Automation, Facilities, Metrology, and Process Development teams.
• Provide technical leadership, mentoring, and guidance to junior engineers and validation resources.
• Support automation and computerized systems validation (CSV) including system assessments and lifecycle documentation.
• Participate in FATs, SATs, design reviews, construction walkdowns, and turnover package development.
• Support change management activities related to equipment, utilities, and system modifications.
• Drive continuous improvement initiatives related to validation processes, documentation, and efficiency.
• Collaborate with contractors, vendors, and system integrators to ensure compliant and timely project delivery.
• Support audits, inspections, and regulatory interactions as required.
• Address technical and project challenges to minimize delays and business impact.
• Support capital projects and strategic initiatives tied to manufacturing expansion and operational readiness.

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline required.
• 6+ years CQV experience in a GMP regulated biotech, pharmaceutical, medical device, or life sciences environment.
• GMP manufacturing equipment
• Clean utilities and HVAC systems
• Laboratory systems and facility infrastructure.
• Strong knowledge of cGMP regulations, FDA/EU expectations, and validation lifecycle principles.
• Experience authoring and executing validation documentation (IQ/OQ/PQ, risk assessments, traceability matrices, reports).
• Experience supporting capital projects, facility expansions, equipment installations, and technology transfers.
• Experience with FATs, SATs, commissioning, and turnover packages.
• Familiarity with computerized system validation (CSV), automation systems, and data integrity principles preferred.
• Fill/Finish manufacturing experience preferred.
• Strong understanding of engineering systems (HVAC, process equipment, utilities, automation).
• Ability to manage multiple projects and priorities in a fast‑paced environment.
• Experience supporting audits and regulatory inspections.
• Strong technical writing, communication, and problem‑solving skills.
• Demonstrated leadership and mentoring capabilities.
• Professional certifications (PMP, CQE, CVP) are a plus.
• Excellent written and verbal communication skills.
• Strong analytical and problem‑solving abilities.
• Ability to influence and collaborate cross‑functionally.
• Effective time management and…