Validation Engineer

We are currently supporting a growing, well-backed cell and gene therapy CDMO in Pittsburgh that is expanding its CQV support team as part of an active GMP project.

They are looking to bring on CQV / Validation Engineers to support a live commissioning and qualification effort tied to bringing equipment online and ready for operation.

This is a hands-on, execution-focused role, supporting CTU mapping and equipment qualification within a GMP environment. It’s a strong opportunity to step into a project where you’ll be directly involved in real CQV execution on active equipment, not just documentation.

Responsibilities

• Supporting CTU (Commissioning Turnover Unit) mapping
• Executing IQ/OQ protocols
• Assisting with equipment qualification activities
• Participating in walkdowns and field execution
• Working alongside validation and engineering teams onsite

Requirements

• 2+ years of hands-on experience in CTU mapping, IQ/OQ execution, and equipment qualification within a GMP environment
• Background in CQV, validation, or commissioning support
• Experience working directly with equipment in the field (not just documentation)
• Comfortable working onsite in Pittsburgh

Equipment scope includes

• Freezers
• Incubators
• Centrifuges
• Biosafety cabinets
• Balances
• Environmental chambers

This is a great opportunity for someone early in their CQV career who already has relevant project experience and is looking to continue building hands-on validation and commissioning experience in a biotech environment.

Please do not reach out if you are a third-party vendor.