Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by FDA, EMEA, ICH etc.
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 comply with 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 executed 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 have to be executed in a highly controlled fashion.
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.
Job ContentKey Areas of accountability/responsibility
Executes several unit operations, manual operations and measurements, conform the applicable production and standard operating instructions, in a clean room environment under cGMP conditions.
Contributes to the overall departmental responsibility for the production under GMP conditions of biopharmaceutical products and intermediates, including maintaining the production suites in proper condition.
Contributes to the departmental responsibility for equipment (related to technical skill of Technician II USP) to assure that maintenance, maintaining documentation and calibration are executed in an adequate and timely fashion, acts as trouble shooter and expert user.
Revises, assists in review and writes documentation.
Implements corrective or preventive actions on execution level and support to Deviation Reports and writing Deviation Action Reports.
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, organize, execute planning.
Execution of validation protocols for which a Technician II USP 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 executed 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 executing 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 DSP has to work accurately and reliably 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 discipline and flexibility in working hours are required.
Knowledge and educational level
Minimal MBO level (e.g. Biotechnology, Process technology).
Good knowledge and working in cGMP environment.
Good knowledge of relevant process unit operations (e.g. fermentation, chromatography, filtration).
Required Level of Experiences
1 or 2 years of relevant experience in the bio (pharmaceutical) fields.