Technician Production Fill & Finish

Overview SUMMARY Production technicians has an operational role in controlling production tools in accordance with GMP rules. DUTIES AND RESPONSIBILITIES Control the production equipment and carry out the IPC according to GMP Execute production tasks according to the defined schedule Participate in the maintenance and cleaning activities of the area Record quality deviations and document them in the quality systems Make yourself available and participate in investigations Carry out the training plan defined by the manager within the deadlines (theoretical and practical) Train other employees in his/her area of expertise as required Perform batch release activities: review and comment on exceptions, close batch records Execute qualification protocols for equipment in the area Participate in continuous improvement efforts through the application of 5S principles and participation in the area Gemba Act as a role model for other team members to ensure timely production of batches and proactively propose problem resolution Contribute positively to a strong culture of integrity, transparency and ethics Act in accordance with legal and compliance requirements and company guidelines Take WFI samples according to the defined schedule and current procedures, ensure the traceability of operations, and report any anomalies to the Quality Control department Delegation to: Senior Technician or Supervisor REQUIREMENTS Technical or scientific training (CFC or equivalent - Bachelor HES - DUT/BTS) in the field of industrial pharmacy or equivalent experience in the chemical, agro-food, pharmaceutical or biotechnology industry (minimum 3 years) Shift work (+ weekend depending on the department) Flexibility in working hours - Occasional daytime work Ability to work in a demanding and highly regulated environment Team player Field experience in cGMP production Specific part: (USP) The USP department is responsible for the fermentation of cells on an industrial scale. The area includes an inoculum part in shakeflask and a cell culture part in single-use bioreactors. The team is also responsible for the processing of the harvest through filtration and centrifugation processes. The position includes regular weekend work. Specific part: (DSP) The DSP department is responsible for the purification of biotech products, through chromatography, filtration, UFDF techniques, up to the bagging of the bulk product. The process also includes viral safety steps. The position includes occasional weekend work. Specific part: (Solution Prep) The solution prep department is responsible for the manufacture and provision of media solutions and buffers, which are required for cell culture and purification activities for the site. The activities include weighing of materials and solution preparation. The department is also responsible for the logistics of the material in production: reception and distribution of single-use items, cleaning and autoclaving of reusable material. Specific part: (F&F) The Fill & Finish department is responsible for the aseptic filling of drug substance into vials with an automated isolator filling line. This includes preparation, set-up and later set-down of the isolator line and the visual inspection of the vials after filling. This is the last production step to obtain a sterile drug product. The position includes occasional weekend work. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. 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