GMP Equipment Qualification Engineer – Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Capgemini Engineering is seeking a Qualification/Validation professional to support the Equipment Requalification program at the Geel site in Belgium. You will work on-site with Engineering, Quality, Manufacturing, and Validation teams to deliver GMP documentation and ensure regulatory compliance.

You will prepare and review IQ/OQ/PQ and CQV activities for utilities, facilities, and process equipment, contributing to a compliant quality transformation initiative.

Qualifications

• Minimum 3 years of experience in equipment qualification or a related role within a pharmaceutical or biopharmaceutical manufacturing environment
• Hands-on experience with IQ / OQ / PQ protocols, CQV methodologies, and GMP / GxP documentation standards
• Experience with utilities, facilities, and process equipment in a regulated manufacturing setting
• Strong understanding of deviation management and CAPA processes, with the ability to contribute to remediation plans
• Fluency in English and Dutch for effective communication with local site teams in Geel

Responsabilités

• Supporting equipment qualification and requalification activities within a GMP-regulated pharmaceutical manufacturing environment, ensuring all activities are executed to the highest quality and compliance standards
• Preparing, executing, and reviewing IQ / OQ / PQ documentation in line with GMP / GxP requirements, contributing to the overall success of the Equipment Requalification workstream
• Contributing to Commissioning, Qualification, and Validation (CQV) activities, including the assessment and requalification of utilities, facilities, and process equipment
• Managing and contributing to deviation identification, CAPA follow-up, and remediation plans related to equipment qualification gaps, ensuring timely and compliant resolution
• Supporting inspection readiness activities when required, ensuring documentation and processes are audit-ready at all times

Connaissances

IQ / OQ / PQ

CQV

GxP documentation

Deviation management

CAPA processes

English

Dutch

Autonomous on-site work

Cross-functional collaboration

Description du poste

Capgemini Engineering is seeking a Qualification/Validation professional to support the Equipment Requalification program at the Geel site in Belgium. You will work on-site with Engineering, Quality, Manufacturing, and Validation teams to deliver GMP documentation and ensure regulatory compliance.

You will prepare and review IQ/OQ/PQ and CQV activities for utilities, facilities, and process equipment, contributing to a compliant quality transformation initiative.