Process Engineer
2 weken geleden
Senior Engineer – MSAT Validation
Leiden, Netherlands – Full-time
Company Description
This global biopharma organization develops and manufactures innovative biotherapeutics, driving excellence in process validation and technology implementation at its Leiden site.
Job Description
As
Senior Engineer – MSAT Validation
, you'll join the Supporting Process Validation (SPV) team within Manufacturing Science & Technology. You'll lead validation activities for key supporting processes such as cleaning, mixing, sterilization, and holding time, ensuring compliance and process optimization.
You'll define validation strategies, support change control, and collaborate across departments to deliver high-quality, inspection-ready outcomes while driving continuous improvement and standardization.
Key Responsibilities:
- Plan and execute validation activities (cleaning, mixing, sterilization, holding time)
- Define validation strategies and support change control
- Write, review, and approve protocols and reports
- Drive process improvements and technology deployment
- Support audit readiness and ensure regulatory compliance
Requirements:
- BSc/MSc in Science, Engineering, or related field
- 4+ years' experience in (bio)pharma validation or process engineering
- Strong knowledge of GMP and regulatory standards (FDA, EMA, ICH)
- Excellent communication, planning, and problem-solving skills
- Lean/6-Sigma experience is a plus
Location:
Leiden, Netherlands
Language:
English required
Interested?
Send your CV to s.-
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