Pharma C&Q Engineer — GMP Validation & Documentation

Belgie Vacature; Beerse; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Electric company car

Meal vouchers

Eco vouchers

Expense allowance

Group insurance

Hospitalization insurance

12 extra leave days (ADV)

Job summary

Select Projects in Belgium is seeking a Commissioning & Qualification Equipment Engineer to prepare, maintain and execute qualification documentation for GMP-critical equipment, utilities and systems. You’ll ensure documentation meets GMP and internal quality standards while collaborating with C&Q leads and project teams.

You’ll participate in qualification testing, support audits, and help keep systems validated and compliant.

Qualifications

• Bachelor's or Master's degree in a scientific or technical field.
• Strong interest in 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.

Responsibilities

• Write qualification documentation including URS, SRS, IA, DQ, IQ, OQ, PQ, QSR and Validation Master Plans.
• Execute and document qualification tests for equipment, utilities and systems.
• Assess the impact of changes, deviations and discrepancies on qualification activities.
• Coordinate document reviews, approval flows and signature processes.
• Follow 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.

Skills

Dutch fluency

English fluency

Technical writing

Education

Bachelor's or Master's degree in a scientific/technical field (Industrial Engineering, Biochemistry, Biotechnology or Pharmaceutical Sciences)

Job description

Select Projects in Belgium is seeking a Commissioning & Qualification Equipment Engineer to prepare, maintain and execute qualification documentation for GMP-critical equipment, utilities and systems. You’ll ensure documentation meets GMP and internal quality standards while collaborating with C&Q leads and project teams.

You’ll participate in qualification testing, support audits, and help keep systems validated and compliant.