Formulation Technician III

Work Schedule

Other

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

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.