Commissioning & Qualification Equipment Engineer | Pharma | Beerse

SELECT PROJECTS (Select); Beerse; On-site; EUR 65,000 - 90,000; Full time

Job summary

SELECT PROJECTS (Select) is seeking an Commissioning & Qualification Equipment Engineer to prepare, maintain and execute qualification documentation for GMP-critical equipment, utilities and systems. You will ensure documentation complies with GMP requirements and internal quality standards, collaborating with C&Q Leads and project teams from initiation through completion.

Your role includes documenting qualification tests, coordinating reviews, and following up on punch lists until closure,

Qualifications

• Experience writing qualification documentation (URS, SRS, IA, DQ, IQ, OQ, PQ, QSR) under GMP.
• Ability to plan and execute qualification tests for equipment, utilities and systems.
• Familiarity with audit support and inspection processes.

Responsibilities

• Prepare, maintain and execute qualification documentation.
• Document qualification tests for equipment, utilities and systems.
• Assess impact of changes on qualification activities and close punch list items.
• Coordinate document reviews, approvals and signatures.
• Support internal and external audits and inspections.
• Archive documents in GMP/GDP-compliant systems.

Skills

Documentation writing

Qualification testing

GMP compliance

Change control

Audit support

Tools

QMS systems

Job description

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