REQUIREMENTS

• BSc in Life Sciences, Biotechnology or related subject
• Demonstrated knowledge of equipment lifecycle requirements in a cGMP setting with preferably 1-3 years of experience
• Knowledge and experience with computer system validations is preferred
• Knowledge of GMP, ICH guidelines and regulatory requirements for ATMPs
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Self-driven and can-do mindset, without compromising quality
• Fluent in English
• As this position is based in Bioscience Park in Leiden (NL), you need to be living in the Netherlands

The Equipment Engineer will be responsible for initiating and maintaining the overall lifecycle of equipment. In this position, the Equipment Engineer will also provide support and their equipment compliance expertise for equipment designed and customized to meet the needs.

Your mission

• Carry out the deployment of new instruments within our Decentralized Manufacturing network
• 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
• Write deviations, change controls and CAPAs
• Play an active role in the improvement of the processes around CSV of laboratory equipment