Commissioning & Qualification Equipment Engineer | Pharma | Beerse

As a Commissioning & Qualification Equipment Engineer, you are responsible for preparing, maintaining and executing qualification documentation for GMP-critical equipment, utilities and systems. You ensure that all documentation complies with applicable GMP requirements and internal quality standards. You work closely with C&Q Leads, Subject Matter Experts and project teams to support qualification projects from initiation through completion. Besides document preparation, you also participate in qualification testing and follow-up activities. Your work plays an important role in ensuring that systems remain in a validated and compliant state. Fortunately, we can count on you for:

• Writing qualification documentation including URS, SRS, IA, DQ, IQ, OQ, PQ, QSR and Validation Master Plans
• Executing and documenting qualification tests for equipment, utilities and systems
• Assessing the impact of changes, deviations and discrepancies on qualification activities
• Coordinating document reviews, approval flows and signature processes
• Following up punch list items and qualification actions until closure
• Supporting internal and external audits and inspections
• Managing document archiving in accordance with GMP and GDP requirements

You are structured, quality-minded and eager to learn. You communicate effectively with different stakeholders and enjoy working in a team-oriented GMP environment. At the same time, you are capable of independently managing documentation and qualification activities.

What you bring

• Bachelor's or Master's degree in a scientific or technical field such as Industrial Engineering, Biochemistry, Biotechnology or Pharmaceutical Sciences
• Strong interest in the pharmaceutical industry and GMP-regulated environments
• Excellent technical writing and documentation skills
• Experience with engineering systems, utilities or manufacturing equipment is an asset
• Fluent in Dutch and English, both written and spoken