Aseptic Filling CQV Engineer – Onsite Validation Lead

Pioneer GMP Consulting; Bloomington (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Pioneer GMP Consulting is seeking an experienced CQV Engineer to support modification and restart of an aseptic vial-filling line and isolator. The engagement is full-time, onsite in Bloomington, with an 8–12 month initial client engagement and potential extensions.

You will perform hands-on qualification activities, IOQ/PQ development, and collaborate with cross-functional teams to return equipment and facility to GMP service.

Qualifications

• Five+ years in CQV/commissioning/validation in GMP pharma/biotech manufacturing.
• Direct experience with aseptic filling or sterile drug-product equipment.
• Experience with filling lines, isolators, vial washers, or depyrogenation tunnels.
• Hands-on IOQ and PQ protocol development and execution.
• Experience testing equipment functions, alarms, interlocks, and automation.
• Documentation of protocol discrepancies and deviations; strong technical writing.

Responsibilities

• Support commissioning and qualification of aseptic vial-filling line and isolator.
• Qualify vial washer, depyrogenation tunnel, filling equipment, and related systems.
• Develop, review, and execute IOQ and PQ protocols.
• Perform field walkdowns and verify installation, configuration, and readiness.
• Test equipment functions, sequences, alarms, and automation interfaces.
• Coordinate testing with Engineering, Automation, Operations, Quality, Validation, vendors, and suppliers.
• Prepare qualification reports and turnover documentation.

Skills

CQV experience

Aseptic filling

Validation

IOQ/PQ protocols

cGMP knowledge

Technical writing

Hands-on field work

On-site work

Tools

Isolator equipment

Vial washer

Depyrogenation tunnel

Filling line equipment

Job description

Pioneer GMP Consulting is seeking an experienced CQV Engineer to support modification and restart of an aseptic vial-filling line and isolator. The engagement is full-time, onsite in Bloomington, with an 8–12 month initial client engagement and potential extensions.

You will perform hands-on qualification activities, IOQ/PQ development, and collaborate with cross-functional teams to return equipment and facility to GMP service.