Equipment Specialist

1 week geleden

Randstad, Nederland Panda International Voltijd

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 (Onsite – Bioscience Park)
  • Languages: English required
  • Interviews: Flexible & fast process

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

Interview Process

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

Apply below to discuss further

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