C&Q Engineer – Commissioning & Qualification Manager

About the role

Our client, a leading pharmaceutical manufacturer, is seeking a C&Q Engineer to lead commissioning and qualification activities across the production site. You will ensure that equipment and systems meet technical and documentary standards in a GMP environment.

Key responsibilities

• Manage the full C&Q documentation lifecycle, including DQ, SRA, DICA, ERES, and MADB.
• Review and approve SAT and IOQ protocols, aligning them with applicable standards.
• Oversee on‑site test execution, guiding testers to maintain real‑time documentary compliance.
• Coordinate cross‑functional activities with Engineering, QA, Automation, and Production teams.
• Resolve blocking points, report progress to the project manager, and assess change impact during qualification phases.
• Draft traceability matrices and keep FAT/SAT test indexes up to date.

Required profile

• Minimum 3 years of C&Q experience in a GMP environment.
• Proficiency in SAT, IOQ, and OQ qualification methodologies.
• Strong documentary rigor and attention to detail.
• Ability to coordinate multidisciplinary project teams.

Required skills

• Design Qualification (DQ)
• System Risk Assessment (SRA)
• Design Input/Change Assessment (DICA)
• Equipment Release Specification (ERES)
• Manufacturing Asset Database (MADB)
• Site Acceptance Test (SAT) protocols
• Installation Qualification (IOQ) and Operational Qualification (OQ)
• Traceability matrices