| Location | Oegstgeest, Netherlands |
|---|---|
| Business Sector | Biotechnology |
| Contact name | Caitlin Girdwood |
| Contact email | |
| Job ref | 25357 |
| Published | 15 days ago |
We are seeking an experienced Equipment & Systems Specialist (Consultant) to lead equipment lifecycle management and compliance activities across a decentralized manufacturing network. This is a 6-month full-time assignment, ideally based in the Leiden region or with the ability to travel to site.
You will play a key role in coordinating qualification and maintenance efforts, supporting audits and system integrity, and writing essential GMP-compliant documentation. This role is critical to maintaining operational readiness and data integrity for QC and manufacturing equipment supporting advanced therapy programs.
Company Description:
This innovative biotech organization is transforming the future of healthcare through scientific excellence and decentralized cell therapy manufacturing. With a strong pipeline in immunology and oncology, the company focuses on unmet medical needs and pushes the boundaries of what's possible. You’ll join a collaborative, purpose-driven environment where your work directly supports life-saving treatments and cutting-edge manufacturing.
Essential Requirements:
Experience managing the full equipment lifecycle, including qualification and maintenance coordination, ideally in a QC and manufacturing setting
Hands-on experience writing URS, IQs, OQs, PQs
Background in a GMP-regulated environment, preferably involving ATMPs (Advanced Therapy Medicinal Products)
BSc in Life Sciences, Biotechnology, or a related field
Excellent communication skills and a proactive, quality-first mindset
Ability to manage shifting priorities with independence and accountability
Fluent in English
Desirable Requirements:
Experience with Computer System Validation (CSV) is a strong plus
Familiarity with ICH guidelines and regulatory expectations for ATMPs
Previous experience supporting multi-site equipment compliance or technical transfers
Additional Insights:
Start Date: ASAP
Duration: 6 months
Employment Type: Full-time Consultant
Location: Netherlands (Leiden region preferred or willingness to travel to Leiden office)