Equipment Validation Specialist

Walker Cole International is currently partnered with a Global European Biopharmaceutical business that is on the trajectory for exceptional growth. To support the exceptional increase in workload, we are searching for an Equioment Validation Specialist in Leiden for a contract of 6 months initially (with potential extension).

The ideal candidate will have the following responsibilities:

• Oversee and coordinate the qualification and maintenance of instruments
• Ensure data integrity and proper user management on the instruments
• Review and assess technical documentation such as vendor IOQs and PQs
• Write equipment lifecycle-related documentation such as URS, IQs, OQs and PQs
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You will ideally have the following skills/experience:

• Demonstrated knowledge of equipment lifecycle requirements in a cGMP setting with preferably 1-3 years of experience
• Knowledge of GMP, ICH guidelines, and regulatory requirements for ATMPs
• Self-driven and can-do mindset, without compromising quality
• Immediately available

Contract details:

•  3 days per week onsite (hybrid)
•  400-650 Euros per day
•  Duration of project: 6 months (with possible extension)
•  Location: Leiden
•  Start date: ASAP

Validation | Commissioning | Qualification | IQ | OQ | PQ | CSV | Equipment | Contract | Contractor | Interim | Freelance | Leiden | Biopharma | Steriles | ATMP