(Senior) Equipment Specialist QC

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

For our Galapagos organization in Leiden (the Netherlands), we are looking for a highly motivated Equipment Specialist to join our Quality Control team.

Scope of the job

Our Equipment Specialist are responsible for initiating and maintaining the overall lifecycle of equipment located at Galapagos in Leiden and its multiple point-of-care facilities. In this position, you will also provide support and their equipment compliance expertise for equipment designed and customized to meet Galapagos’ needs.

Your role

• Carry out the deployment of new instruments within our Point of Care Manufacturing network
• Oversee and coordinate the qualification and maintenance of instruments
• Create and manage a multi-site maintenance and audit trail program
• Ensure data integrity and proper user management
• Review and assess technical documentation such as vendor IOQs and PQs
• Write equipment lifecycle related documentation such as URS, IQs, OQs and PQs
• Write procedures, deviations, change controls and CAPAs
• Participate in the on-call support team for temperature related alarms

Who are you? 

• 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

What’s in it for you?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

We are Galapagos: together we make it happen…!