Formulation Technician II

Work Schedule Other Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description 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. Responsibilities: 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 (e.g. working on 5S, performing Fit & Finish inspections). Ensures GMP documentation is properly filled in during production as required by cGMP. Makes sure that required corrections in cGMP documentation, as required by qualified reviewers or supervisors, are made in a timely manner and in compliance with cGMP . Contributes to the departmental responsibility for equipment (related to technical skill of Technician II DSP) 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. 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 for which a Technician II DSP 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 in compliance with cGMP Quality System and the Thermo Fisher EH&S requirements. Other miscellaneous office tasks. Requirements: Minimal MBO level (e.g. Biotechnology, Process technology). Knowledge of relevant process unit operations (e.g. chromatography, filtration or UF/DF). What We Offer: Competitive Pay Performance Related Bonus where eligible Annual merit performance-based increase Excellent Benefits Medical benefits Paid Time Off/Annual Leave Employee Referral Bonus Career Advancement Opportunities