Senior COTS C&Q Engineer

Senior COTS C&Q Engineer

As a Commissioning & Qualification (C&Q) Engineer for Small Equipment and Commercial Off-The-Shelf (COTS) systems in a laboratory and GMP production setting, you will lead C&Q activities from design through execution. Acting as the SME for C&Q, you will ensure project milestones are met safely, on schedule, and in compliance with system and regulatory requirements.

Key Responsibilities:

• Lead and manage C&Q lifecycle activities for lab and GMP production equipment (e.g. QRA, DV, RTM, FAT, SAT, IOV, VSR).
• Act as C&Q Subject Matter Expert and compliance lead, guiding suppliers and coordinating cross-functional activities.
• Oversee protocol execution, walk-downs, testing, troubleshooting, and deviation management.
• Drive planning, tracking, KPI reporting, and risk mitigation for assigned systems.
• Manage turnover from construction and support system start-up.
• Review and close change controls; ensure C&Q personnel are properly trained.
• Support the development of User Requirement Specifications (URS) and risk assessments.

Requirements:

• 5+ years’ experience in C&Q for GMP equipment in CAPEX projects.
• Technical degree in Engineering or related field; fluent in English.
• Strong knowledge of GMP, safety, and risk-based approaches.
• Experience in biotech/sterile/single-use equipment is preferred.
• Strong communication, leadership, and stakeholder engagement skills.

Equipment Scope Includes (but not limited to):

GMP Pilot Plant: Biosafety Cabinets, Cryo Freezers, Shaker Incubators, Thawing Cabinets, Tube Sealers/Welders, Centrifuges, UV-Vis Spectrophotometers, Metabolite Analyzers, Particle Counters, Microscopes, etc.

GMP Lab: HPLC-MALS, LC-MS, UPLC-CAD, ddPCR, qPCR, Cell Counters, Nucleic Acid Extraction Robots, Microplate Readers, Analytical Balances, and more.