USP Technician II

4 weken geleden

Groningen, Groningen, Nederland ThermoFisher Scientific Voltijd

Job Description

How will you make an impact?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our organization of more than 120,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .

Our site in Groningen is part of the world-class Pharma Services of Thermo Fisher Scientific. We operate in a sophisticated and highly regulated environment. You'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe You will have a real-world impact. Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to state-of-the-art (including Single Use Technologies such as Single Use Bioreactors).

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications. This type of facility has to follow rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulations.

The production activities have to be performed in an efficient and effective manner to assure the sites overall competitiveness. In addition, due to the very high value of intermediates and products, production activities are preformed in a highly controlled fashion (Cleanroom environment).

The Job

  • Performs several unit operations, manual operations and measurements, conform the applicable production and standard operating instructions, in a clean room environment under cGMP conditions.
  • Chips in to the overall departmental responsibility for the production under GMP conditions of biopharmaceutical products and intermediates, including maintaining the production suites in accurate condition (e.g. working on 5S, performing Fit & Finish inspections).
  • Ensures GMP documentation is accurately filled in during production.
  • Makes sure that required corrections in cGMP documentation are made in a timely manner and in compliance with cGMP.
  • Chips in to the departmental responsibility for equipment (related to technical skill of Technician II USP) to assure that maintenance, maintaining documentation and calibration are performed in an adequate and timely fashion, acts as trouble shooter and specialist.
  • Revises, assists in review and writes documentation.
  • Implements corrective or preventive actions on execution level.
  • Support and implementation of new procedures and/or equipment in the OPS department.
  • Signals problems and communicates to the responsible person.
  • Assists in execution of validation protocols.
  • Trains co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
  • All activities should be performed within the department in compliance with cGMP Quality System and the Thermo Fisher EH&S requirements.
  • A shift pattern is applicable.

Complexity of the Job

  • The Thermo Fisher site in Groningen manufactures many products for clinical trials and commercial applications. This implies that the production activities range from performing a totally new production run for the first time, to the routine production of a commercial batch.
  • Due to the diversity of costumers, and their associated products, the applicable processing steps are very diverse.
  • Given the high value of the products and intermediates the Technician II USP has to work accurately and optimally and in agreement with cGMP and EH&S.
  • Due to involvement in the timely execution of manufacturing processes under cGMP conditions, a fair amount of subject area and flexibility in working hours are required.
  • The job of a technician II mostly interacts within the USP team and occasionally requires interaction with the MSAT and Quality assurance team.

You have

  • Minimal MBO level (e.g. Biotechnology, Process technology or equivalent education).
  • Knowledge of relevant process unit operations (e.g. Cell culture, Bioreactors or Cell banking).

Competences

  • Coordinated
  • Integrity
  • Strictness
  • Quality oriented
  • Result driven
  • Verbal communication
  • Written communication
  • Flexibility

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


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