Return to search results

Equipment Validation Specialist

Equipment Validation Specialist

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact nameCaitlin Girdwood
Contact email
Job ref24637
Published3 days ago

An international biopharmaceutical company is seeking an Interim Equipment Specialist to support equipment lifecycle management across multiple Decentralized Manufacturing (DM) facilities in Europe. This role ensures equipment compliance, qualification, and maintenance in a cGMP setting, supporting critical CAR-T and biologics production.

Key Details:

  • Start Date: ASAP
  • Contract Duration: 6 months
  • Location: Leiden, Netherlands 
  • Languages: English required
  • Interviews: Flexible & fast process
  • On vs off site: Hybrid (50/50)

Responsibilities

  • Equipment Deployment – Oversee and manage new instrument rollout across the Decentralized Manufacturing network.
  • Qualification & Maintenance – Coordinate installation, qualification (IQ/OQ/PQ), and maintenance of laboratory and production equipment.
  • Compliance & Documentation –
  • Ensure data integrity and user management on instruments.
  • Review and assess vendor documentation (IOQs, PQs).
  • Write URS, IQ, OQ, PQ, deviations, change controls, and CAPAs.
  • Process Improvement – Support continuous improvement in computer system validation (CSV) for lab equipment.

    Requirements

    • BSc in Life Sciences, Biotechnology, or related field.
    • 1-3 years of experience in equipment lifecycle management within a cGMP setting.
    • Experience with computer system validation (CSV) preferred.
    • Knowledge of GMP, ICH guidelines, and ATMP regulatory requirements.
    • Strong communication skills and ability to manage stakeholders.
    • Flexible, self-driven, and problem-solving mindset.
    • Must be based in the Netherlands (Leiden, Bioscience Park).

    Why This Role?

    • Impactful Work – Play a key role in supporting life-changing therapies in oncology and immunology.
    • Cutting-Edge Science – Work with advanced equipment in a CAR-T and biologics manufacturing environment.
    • Fast-Paced & Dynamic – Opportunity to optimize processes and drive improvements in equipment validation.

    Interview Process

    • 1st Interview – With Hiring Manager & relevant stakeholders
    • 2nd Interview – If required
    • Quick Decision Process – Flexible scheduling