Technician Production Fill & Finish

Incyte; Yverdon-les-Bains; On-site; CHF 68,000 - 110,000; Full time

Job summary

Incyte is seeking Production Technicians to support GMP-driven manufacturing operations. You will control production tools, execute tasks per schedule, participate in area maintenance, and document deviations in quality systems.

Responsibilities include batch release review, equipment qualification, 5S-driven improvements, and training of team members while ensuring traceability and compliance with regulatory requirements. Weekend work is involved as needed.

Qualifications

• Technical or scientific training in industrial pharmacy or equivalent with 3+ years in chemical/pharma/biotech
• Shift work including weekends depending on department
• Ability to work in a highly regulated environment
• Team-oriented and adaptable to changing priorities

Responsibilities

• Control production equipment and perform IPC according to GMP
• Execute production tasks according to the defined schedule
• Participate in maintenance and cleaning activities of the area
• Record quality deviations and document them in the quality systems
• Engage in investigations and corrective actions
• Carry out the training plan defined by the manager within deadlines
• Train other employees in area of expertise as required
• Perform batch release activities: review exceptions, close batch records
• Execute qualification protocols for equipment in the area
• Participate in 5S and Gemba-based continuous improvement
• Act as role model to ensure timely production and propose solutions
• Contribute to integrity, transparency and ethics culture
• Comply with legal and company guidelines
• Take WFI samples per schedule and ensure traceability, report anomalies to QC
• Delegation to Senior Technician or Supervisor

Skills

GMP knowledge

Team player

Shift work

Flexibility

Biotech industry experience

Education

CFC / Bachelor HES / DUT/BTS in industrial pharmacy

Job description

Summary

Production technicians has an operational role in controlling production tools in accordance with GMP rules.

Aperçu

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

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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