CQ Lead

Location:

Southeast U.S. (south of Washington DC, East of Mississippi River)

Job Summary

The CQ Lead is responsible for planning, executing, and documenting commissioning and qualification activities for systems within a GMP‑regulated biopharmaceutical facility. This role ensures systems in the assigned area are installed, integrated, and operating safely and effectively, consistently meeting product quality, patient safety, and data integrity requirements in line with ISPE, GAMP 5, ASTM E2500, and site standards.

You will lead CQ planning and execution for your area scope, including URS development, risk and impact assessments, CQ strategy, protocol preparation (DQ/IQ/OQ/PQ), execution oversight, and generation of audit‑ready documentation. The role requires strong coordination with Engineering, Operations, Quality, Automation, and EHS to align CQ activities with project milestones, start‑up, and handover.

Scope Areas

• Utilities, HVAC, cold rooms
• Upstream
• Downstream
• QC Lab

Ideal Background

• Bachelor’s degree in Engineering or related field, or equivalent experience.
• 8+ years in pharmaceutical/biotech or regulated life‑sciences, with strong exposure to CQ activities for facility, utilities, or process equipment in a defined area.
• Deep knowledge of GMP, FDA expectations, and risk‑based C&Q frameworks (ISPE, GAMP 5, ASTM E2500).
• Proven experience supporting greenfield or large capital project start‑ups.
• Hands‑on experience with electronic CQ/validation systems (e.g., Kneat, ValGenesis, EvalRoche) and CMMS (e.g., SAP) is a plus.
• Strong leadership and coordination skills, able to manage multi‑stakeholder teams, resolve technical issues, and maintain strict safety and compliance standards.
• Willingness to relocate to client site during the required phases of the project.