Senior C&Q Engineer, GMP Pharma Equipment Qualification

Panda International; Beerse; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Panda International is seeking a C&Q Engineer to join our pharmaceutical project team in Beerse, Belgium. The role focuses on commissioning and qualification of equipment and systems within a GMP environment, ensuring validated state throughout the lifecycle and readiness for production.

You will collaborate with Engineering, Operations, Quality and Maintenance, drive QMS improvements, and mentor external C&Q engineers while maintaining strong regulatory alignment with Annex 1 and 21 CFR Part 11.

Qualifications

• Extensive experience in C&Q within a GMP environment.
• Strong knowledge of GMP regulations incl. Annex 1 and 21 CFR Part 11.
• Qualification of equipment, production systems, utilities and facilities.
• Ability to operate both strategically and hands-on in a pharma setting.
• Excellent communication and stakeholder engagement at all levels.
• Master's degree in Engineering, Science, or equivalent required.

Responsabilités

• Act as C&Q SME for equipment qualification activities.
• Develop, execute and maintain commissioning and qualification strategies.
• Ensure equipment remains validated and compliant throughout lifecycle.
• Collaborate with Engineering, Operations, Quality and Maintenance.
• Represent C&Q during regulatory and client quality audits.
• Communicate qualification strategy, progress and status to stakeholders.
• Drive QMS, C&Q process improvements and tool adoption.
• Mentor external C&Q engineers.

Connaissances

C&Q Engineering

GMP compliance

Annex 1

21 CFR Part 11

English communication

Dutch language

Formation

Master's degree in Engineering or related field

Description du poste

Panda International is seeking a C&Q Engineer to join our pharmaceutical project team in Beerse, Belgium. The role focuses on commissioning and qualification of equipment and systems within a GMP environment, ensuring validated state throughout the lifecycle and readiness for production.

You will collaborate with Engineering, Operations, Quality and Maintenance, drive QMS improvements, and mentor external C&Q engineers while maintaining strong regulatory alignment with Annex 1 and 21 CFR Part 11.