USP Technician II

Work Schedule

Other

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Purpose of the Job
Make biopharmaceutical products following international quality standards set by the FDA, EMEA and ICH and other regulatory organisations.

About the Job
On the Groningen site we make medicines for clinical trials (phases I, II, and III) and commercial use using mammalian cell lines. This position is for the USP (Upstream Processing) department.
In this department you will be working in the cleanroom with the cells (Laminar Airflow cabinets) directly and going through the process of thaw up to the large bioreactor volumes of 1000L/2000L. 

We follow strict rules to make sure everything is done safely adhering to the GMP-compliance regulations set by the regulatory organisations.

Our work must be precise and efficient to protect the quality and value of our products.

What You’ll Do

• Follow detailed step-by-step procedures to manufacture biopharmaceutical products in a cleanroom environment.
• Maintain an organized and efficient workspace using the 5S method and Fit & Finish inspections.
• Operate critical processing equipment, including LAF hoods, wave-based culture mixing systems, and bioreactors.
• Accurately complete production protocols and resolve documentation issues while ensuring compliance.
• Maintain and troubleshoot equipment, documenting maintenance activities.
• Contribute to continuous improvement by updating procedures and reviewing documentation.
• Assist in setting up and validating new processes and equipment.
• Support quality control efforts by performing key tests and reporting any deviations.
• Train colleagues on processes and equipment, verifying training accuracy.
• Uphold safety and quality standards to ensure seamless production operations.

Why This Job is Exciting
At Thermo Fisher’s Groningen site, we manufacture a diverse range of products for both clinical trials and commercial use. This diversity means production tasks can vary from first-time production runs to routine commercial batch manufacturing.

Given the variety of customers and products, processing steps also differ significantly. Due to the high value of our products and intermediates, accuracy, reliability, and compliance with cGMP and EH&S regulations are crucial.

This job requires flexibility and teamwork. You’ll mostly work with the USP team, but sometimes you’ll collaborate with other departments such as the Down Stream (DSP), Media Buffer Preparation (MBP), Manufacturing Science and Technology (MSAT) and Quality Assurance (QA) teams.

What You Need

• A diploma in Biotechnology, Biology and Medical Labratory Research, Process Technology, or a similar field in Life Sciences (i.e. MLO or HLO).
• Knowledge of basic lab processes (e.g., cell culture, bioreactors, microbiology or cell banking).
• Completed MBO (or similar level of education) in a related field.

Skills That Will Help You Succeed

• Teamwork
• Staying organised
• Focusing on quality
• Working towards results
• Clear communication (speaking and writing)
• Being flexible and open to change