Sr. Commissioning & Qualification (C&Q) Engineer

About the role

We are seeking a senior Commissioning & Qualification (C&Q) Engineer to lead the installation, start‑up and validation of sterile fill‑finish equipment in a GMP environment. The role involves hands‑on work with equipment, utilities and facilities to ensure operational readiness and compliance.

Key responsibilities

• Commission, install, and perform Site Acceptance Testing (SAT) on sterile fill‑finish equipment.
• Qualify prefilled syringe lines, isolators, autoclaves, cleanrooms (Grade C & D), warehouses, cold storage and GMP utilities such as HVAC, WFI, steam, nitrogen, pure air and chilled water.
• Develop, execute and review validation documentation including VMPs, IQ/OQ/PQ protocols and Validation Summary Reports.
• Manage deviations and support equipment, utility and facility qualification activities.
• Provide troubleshooting and operational support during startup and ongoing production.

Required profile

• Strong experience in aseptic sterile fill‑finish manufacturing.
• Hands‑on C&Q experience with equipment, utilities and facilities.
• Proven ability to write and execute validation documents and manage deviations.
• Excellent problem‑solving and troubleshooting skills.

Required skills

• Commissioning and installation of sterile fill‑finish equipment.
• Site Acceptance Testing (SAT).
• Qualification of prefilled syringe lines, isolators, autoclaves, cleanrooms (Grade C & D), warehouses and cold storage.
• GMP utilities expertise (HVAC, WFI, steam, nitrogen, pure air, chilled water).
• Validation documentation (VMP, IQ, OQ, PQ, Validation Summary Reports).
• Deviation management.
• Advanced troubleshooting.