CQV Engineer (Fill-Finish Validation)

Location: Pennsylvania (Onsite) | Duration: 12+ Months Contract

About the Role

We are seeking a CQV Engineer with experience in pharmaceutical or biotechnology manufacturing to support commissioning, qualification, and validation activities in a GMP-regulated environment. The ideal candidate will have hands-on experience with aseptic fill-finish processes, equipment qualification, and validation documentation.

Responsibilities

• Execute IQ, OQ, PQ, and PPQ protocols.
• Qualify equipment such as isolators, autoclaves, parts washers, or perform smoke studies and air pattern analysis.
• Prepare, review, and execute validation protocols and reports.
• Support aseptic or sterile fill-finish manufacturing in a GMP-regulated environment.

Requirements

• 5–10 years of CQV or validation experience in pharmaceutical or biotechnology manufacturing.
• Hands-on experience supporting aseptic or sterile fill-finish manufacturing.
• Working knowledge of FDA regulations, cGMP, and Good Documentation Practices (GDP).

Preferred Qualifications

• Experience with Groninger, Syntegon, Optima, or similar fill-finish equipment.
• Experience supporting greenfield or startup manufacturing facilities.
• Experience with formulation and preparation areas in addition to fill-finish operations.
• Strong troubleshooting, documentation, and cross-functional communication skills.