C&Q Engineer

S4 Analytics LLC; New York (NY); On-site; USD 100,000 - 160,000; Full time

Job summary

S4 Analytics LLC is seeking a Sr. Commissioning & Qualification (C&Q) Engineer in the United States to lead commissioning, installation, SAT, and qualification of sterile fill-finish systems.

You will support startup activities, assist troubleshooting, and drive operational readiness across cleanrooms and GMP utilities. The role requires hands-on C&Q experience with equipment, utilities, and facilities, plus proven ability to write and execute validation documentation and manage deviations.

Qualifications

• Strong experience in aseptic sterile fill-finish manufacturing.
• Hands-on C&Q experience with equipment, utilities, and facilities.
• Experience writing/executing validation documents and managing deviations.
• Strong troubleshooting and problem-solving skills.
• Looking for hands-on professionals with utility and/or equipment qualification experience.

Responsibilities

• Commissioning, installation, SAT, and qualification of sterile fill-finish equipment.
• Support startup, troubleshooting, and operational readiness.
• Qualify prefilled syringe lines, isolators, autoclaves, cleanrooms (Grade C & D), warehouse, cold storage, and GMP utilities (HVAC, WFI, Steam, Nitrogen, Pure Air, Chilled Water).
• Develop and execute validation documentation (VMP, IQ/OQ/PQ, Validation Summary Reports).
• Manage deviations and support equipment, utility, and facility qualification activities.

Skills

Aseptic sterile fill-finish

C&Q for equipment

Validation document writing

Troubleshooting

Deviations management

Job description

Job Title: Sr. Commissioning & Qualification (C&Q) Engineer

Location: United States

Key Responsibilities:

• Commissioning, installation, SAT, and qualification of sterile fill-finish equipment.
• Support startup, troubleshooting, and operational readiness.
• Qualify prefilled syringe lines, isolators, autoclaves, cleanrooms (Grade C & D), warehouse, cold storage, and GMP utilities (HVAC, WFI, Steam, Nitrogen, Pure Air, Chilled Water).
• Develop and execute validation documentation (VMP, IQ/OQ/PQ, Validation Summary Reports).
• Manage deviations and support equipment, utility, and facility qualification activities.

Requirements:

• Strong experience in aseptic sterile fill-finish manufacturing.
• Hands-on C&Q experience with equipment, utilities, and facilities.
• Experience writing/executing validation documents and managing deviations.
• Strong troubleshooting and problem-solving skills.
• Looking for hands-on professionals with utility and/or equipment qualification experience.