Thermo Fisher Scientific is hiring a
Formulation Technician III
Groningen, Netherlands
Work Schedule
Other
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
What sets this opportunity apart
Join our world-class team at Thermo Fisher Scientific Inc. in Groningen, where you will have the opportunity to contribute to groundbreaking biopharmaceutical production. Our ambitious and diverse team strictly adheres to cGMP standards to deliver outstanding products that have a tangible impact on global health.
Job Content Key Areas of Accountability/Responsibility
- Complete a range of unit operations, manual tasks, and measurements in accordance with production protocols and SOPs within a cleanroom environment.
- Lead the cleanroom team, addressing customer and partner concerns as the primary contact.
- Ensure biopharmaceutical products and intermediates are produced under cGMP conditions, maintaining production suites meticulously.
- Report production room issues to the ENG department through service requests.
- Complete GMP documentation accurately and promptly, ensuring compliance with cGMP.
- Perform equipment maintenance and calibration, acting as a troubleshooter and expert user.
- Revise, review, and draft documentation, proposing and successfully implementing corrective or preventive actions.
- Support the transfer and understanding of new technologies to the OPS department.
- Facilitate the implementation of new procedures or equipment in the OPS department.
- Exhibit a proactive attitude to identify and resolve practical problems, communicating solutions to the responsible person.
- Communicate technical issues with suppliers.
- Independently coordinate and implement planning.
- Write and complete validation protocols.
- Train co-workers on specific unit operations or equipment, approving on-the-job trainings.
- Independently complete all departmental activities in compliance with the cGMP Quality System and Thermo Fisher EH&S requirements.
- Signal problems to the Supervisor and/or Quality group.
Complexity of the Job
- The Groningen site handles a diverse range of biopharmaceutical products for clinical trials and commercial applications, from new production runs to routine commercial batch production.
- The variability of customers and products necessitates a wide range of processing steps.
- Given the high value of our products and intermediates, the Tech III must evaluate situations and their potential impacts on product quality, yield, EH&S, and cGMP compliance.
- Timely execution of manufacturing processes under cGMP conditions requires outstanding organizational skills, flexibility in working hours, and a deep understanding of the field.