Equipment Specialist

Panda International

  • Leiden, Zuid-Holland
  • Vast
  • Voltijds
  • 1 maand geleden
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 settingHands-on experience writing URS, IQs, OQs, PQsBackground in a GMP-regulated environment, preferably involving ATMPs (Advanced Therapy Medicinal Products)BSc in Life Sciences, Biotechnology, or a related fieldExcellent communication skills and a proactive, quality-first mindsetAbility to manage shifting priorities with independence and accountabilityFluent in EnglishDesirable Requirements:Experience with Computer System Validation (CSV) is a strong plusFamiliarity with ICH guidelines and regulatory expectations for ATMPsPrevious experience supporting multi-site equipment compliance or technical transfersAdditional Insights:Start Date: ASAPDuration: 6 monthsEmployment Type: Full-time ConsultantLocation: Netherlands (Leiden region preferred or willingness to travel to Leiden office)

Panda International