USP Technician

Job description

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, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials, Working at heights Job Description Purpose of the Job Make biopharmaceutical products following international quality standards set by the FDA, EMEA and ICH and other regulatory organizations. We follow strict rules to make sure everything is done safely adhering to the GMP-compliance regulations set by the regulatory organizations. Our work must be precise and efficient to protect the quality and value of our products. About the Job On the Groningen site we produce 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 cells and follow the process from thawing to bioreactors of 1000L/2000L. What You’ll Do Manufacturing biopharmaceutical products in a cleanroom environment by following detailed procedures while maintaining an organized workspace. Operate critical processing equipment, including LAF hoods and bioreactors. Document activities in production protocols and resolve comments after review Maintain and troubleshoot equipment Updating and creating Standard Operating Procedures and logbooks. Take samples during the process that will be analyzed by the Quality Control Training of new hires when completely trained (not mandatory) 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 Laboratory 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 vocational degree (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