Biopharmaceutical Equipment Specialist
6 dagen geleden
Panda International, a leading international biopharmaceutical company, is seeking an experienced Interim Equipment Lifecycle Manager to support equipment lifecycle management across multiple Decentralized Manufacturing facilities in Europe.
The ideal candidate will ensure equipment compliance, qualification, and maintenance in a cGMP setting, supporting critical CAR-T and biologics production. Key details include:
- Start Date: ASAP
- Contract Duration: 6 months
- Location: Leiden, Netherlands (Onsite – Bioscience Park)
- Languages: English required
- Interviews: Flexible & fast process
Responsibilities include:
- 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 include:
- 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.
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