Validation Engineer

Position: Senior CQV Engineer – Fill Finish Systems (2 Openings)

Duration: Contract

We are seeking two experienced Senior CQV Engineers to support commissioning, qualification, and validation activities for a large-scale biopharmaceutical manufacturing facility. The ideal candidates will have strong experience with aseptic fill-finish systems and will lead CQV activities for critical manufacturing equipment, utilities, and processes while ensuring compliance with cGMP, FDA, EMA, and industry standards.

• Lead commissioning, qualification, and validation activities for fill-finish manufacturing systems.
• Develop and execute Validation Master Plans (VMPs), risk assessments, IQ/OQ/PQ protocols, and summary reports.
• Support technology transfer, new product introduction (NPI), process validation, and regulatory inspection readiness activities.
• Perform system impact assessments, change control evaluations, deviation investigations, and CAPA implementation.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Project teams to ensure successful project execution.
• Ensure compliance with GMP regulations, data integrity requirements, and validation best practices.
• Provide technical guidance and mentorship to junior CQV and validation personnel.

• 5+ years of CQV/Validation experience within pharmaceutical, biotech, or biologics manufacturing environments.
• Hands‑on experience qualifying aseptic fill‑finish equipment and processes.
• Strong experience executing IQ/OQ/PQ protocols and validation documentation.
• Knowledge of cGMP, FDA, EMA, ISPE, and industry validation standards.
• Experience supporting deviations, investigations, change controls, and CAPAs.

• Vial filling lines
• Isolators
• Restricted Access Barrier Systems (RABS)
• Autoclaves
• Cappers
• Visual inspection systems
• Filling lines
• Packaging lines
• CIP skids

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Strong communication and cross‑functional collaboration skills.
• Experience supporting large‑scale facility startup, expansion, or capital projects.
• Ability to work independently in a fast‑paced project environment.