Come join an exciting team part of a huge site expansion in the pharmaceutical gene therapy industry. Our client is looking for a CQV Lead with in depth knowledge working with gene therapy equipment.

*Long term contract: 1-5 years

*Excellent pay rate

*Onsite in Lebanon, IN

REQUIRED EXPERIENCE:

• 15+ years CQV Experience
• At least 7 years with Gene Therapy Equipment
• Experience writing protocols (potentially from scratch) for validation of the equipment and then running the execution
• Strong technical writing skills and hands-on execution experience with facility/equipment qualification
• Knowledge of single‑use technologies, aseptic processes, utilities, and computerized system validation
• Degree in Engineering or Life Sciences

Responsibilities:

• Develop and execute IQ/OQ/PQ protocols for upstream, downstream, and aseptic processing equipment (e.g., single‑use bioreactors, TFF/chromatography systems, isolators, fill‑finish equipment).
• Author URS, RTM, FAT/SAT, and summary reports using risk‑based validation methodologies
• Lead protocol execution, troubleshooting, deviation management, and CAPA documentation.
• Ensure audit-ready compliance with cGMP
• Coordinate with vendors and cross-functional teams; provide guidance to junior engineers.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.