Pharma C&Q Engineer – Packaging Line Commissioning Lead

Katalyst CRO; Cincinnati (OH); Sur place; USD 90 000 - 150 000; Plein temps

Résumé du poste

Katalyst CRO in Cincinnati seeks an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion involving four new packaging lines. This hands-on role sits within a pharmaceutical packaging operation for final drug product.

You will lead C&Q activities, develop and execute documentation, perform floor walkdowns, and ensure systems are built, installed, and verified to specification for GMP turnover.

Qualifications

• Experience in commissioning and qualification activities in a regulated pharma environment.
• Understanding of GMP, FDA requirements and manufacturing processes.
• Ability to perform equipment walkdowns and verify system performance.

Responsabilités

• Lead and execute commissioning and qualification activities for four new packaging lines.
• Develop, author, review, and execute C&Q documentation (plans, protocols, test scripts, punch lists, turnover packages).
• Perform hands-on equipment walkdowns, verifications, and commissioning checks on the manufacturing floor.
• Manage punch list tracking and resolution through to turnover and acceptance.
• Collaborate with vendors, engineering, construction, and operations to ensure installed systems meet design specifications.
• Support Site Acceptance Testing (SAT) for incoming packaging equipment.
• Ensure all C&Q activities comply with FDA, GMP, and site standards.
• Apply manufacturing process knowledge to reflect real-world operational requirements in acceptance criteria.
• Partner with Quality, Manufacturing, and Engineering to enable GMP turnover of commissioned systems.
• Maintain accurate C&Q records in line with data integrity standards.

Connaissances

Commissioning & Qualification

Manufacturing process knowledge

FDA GMP compliance

Equipment walkdowns

Description du poste

Katalyst CRO in Cincinnati seeks an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion involving four new packaging lines. This hands-on role sits within a pharmaceutical packaging operation for final drug product.

You will lead C&Q activities, develop and execute documentation, perform floor walkdowns, and ensure systems are built, installed, and verified to specification for GMP turnover.