| Location | Leiden, Netherlands |
|---|---|
| Business Sector | Pharmaceutical |
| Contact email | |
| Job ref | 26103 |
| Published | about 1 hour ago |
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 m.gomes@panda-int.com