Process Equipment C&Q Engineer

Darwin Recruitment; Mainz; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading recruitment agency is seeking a Commissioning & Qualification Engineer in Mainz, Germany. You will support equipment installation and GMP qualification activities across pharmaceutical manufacturing sites. Candidates should have a degree in engineering and strong experience in C&Q for pharma equipment. Fluency in German and a deep understanding of GMP principles are essential for this role, which involves executing qualifications, reviewing documentation, and complying with internal and external quality standards.

Qualifikationen

• Strong experience in commissioning and qualification of pharmaceutical process equipment.
• Ability to prepare and review C&Q documentation and test plans.
• Understanding of P&IDs and equipment documentation.

Aufgaben

• Execute commissioning, IQ/OQ/PQ qualification for pharmaceutical equipment.
• Prepare and review C&Q documentation, including protocols and reports.
• Support equipment start-up and performance verification.

Kenntnisse

Commissioning

Qualification

GMP principles

Fluency in German

Troubleshooting

Ausbildung

Degree in Engineering (Mechanical, Chemical, or Bioprocess)

Jobbeschreibung

We are seeking a Commissioning & Qualification (C&Q) Engineer with strong experience in pharmaceutical process equipment. You will support equipment installation, commissioning, and GMP qualification activities across pharmaceutical and biotech manufacturing sites in Germany.

Key Responsibilities

• Execute commissioning, IQ/OQ/PQ qualification for pharmaceutical process equipment (e.g., bioreactors, mixers, CIP/SIP systems, filtration systems, filling/packaging equipment).
• Prepare and review C&Q documentation: protocols, test plans, reports, risk assessments.
• Support FAT/SAT, equipment start-up, troubleshooting, and performance verification.
• Ensure full compliance with EU GMP, Annex 15, GAMP 5, and internal quality standards.
• Collaborate with engineering, QA, and suppliers to meet project deadlines and quality expectations.

Requirements

• Degree in Engineering (Mechanical, Chemical, Bioprocess, or related).
• Experience in pharma/biotech equipment C&Q is essential.
• Strong understanding of GMP and validation principles.
• Fluency in German (C1 or native); English preferred.
• Ability to interpret P&IDs, URS/FS/DS, and equipment documentation.
• Willingness to work onsite in Germany.

Greg King