MBP Technician II
Job and Position Context
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).
Controlled production activities and compliance to cGMP rules, regulations and guidelines is essential for the suitability of the clients’ products and the license to operate for the site. Main contacts are within own department.
Key Areas of accountability/responsibility
- Performs several unit operations, manual operations and measurements, conform the applicable production and standard operating instructions, in a clean room environment.
- Chips in to the overall departmental responsibility for the production of biopharmaceutical products and intermediates, including maintaining the production suites in proper condition.
- Tends to equipment (related to technical skill of Tech II) to assure that maintenance, maintaining documentation and calibration are performed in an adequate and timely fashion, acts as trouble shooter and expert user.
- Assists in review, revision and writing documentation
- Supports of Implementing corrective or preventive actions on execution level.
- Support and implementation of new procedures and/or equipment in the OPS department, including support to changes (CRF).
- Signals problems and communicates to the responsible person.
- Sets up, coordinate, complete planning.
- Execution of validation protocols for which a Tech II technical skill is required.
- 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 coherent with cGMP Quality System and the Thermo Fisher EH&S requirements.
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 Tech II has to work accurately and reliably and in agreement with cGMP and EH&S.
- Due to involvement in the timely execution of manufacturing processes, a fair amount of strictness and flexibility in working hours are required.
Knowledge and educational level
- Good knowledge of operating and working in cGMP environment.
- MBO level (e.g. Biotechnology, Process technology) a plus.
- Good knowledge of relevant process unit operations (e.g. media preparation, filtration) a plus.
Required Level of Experiences
- 1 to 2 years of meaningful experience in the bio (pharmaceutical) field or combination of experience and education.
- Problem analysis
- Planning and organization
- Quality driven
- Result orientation
- Verbal communication