CSV Engineer

Founded in 2005, agap2 is a European company of engineering and operational consulting. We operate in the sectors of Energy, Infrastructure, Transport, Chemistry, Life Sciences and IT.

Today, the agap2 group has a team composed of over 5000 qualified doctors and engineers. We work on projects around the world from our offices in Europe - Switzerland, Germany,
Belgium, Spain, France, Netherlands, Portugal, and UK.

We attach as much importance to the spirit, ambition, dynamism, and daring as to the expertise of our teams. Attached to these basic human values, we recruit high-value profiles to strengthen our technical teams and our industrial partners in Switzerland (offices in Basel , Zurich and Lausanne).

Tasks

The CSV engineer is in charge of ensuring the validated state of computerized systems on
manufacturing site, including laboratory equipment.

• Create the requested CSV documents: risk analyses, traceability matrixes, validation protocols
• Organize the review of the CSV documents by the QA teams
• Execute the CSV test and support the CSV timelines
• Write CSV reports
• Work in close collaboration with the CSV and CQV lead Engineers
• Interact closely with Process Engineers, Automation Team (EMR), PM and QA
• Ensure GAMP5 compliance, follow the ASTM guidelines

Requirements

• Engineering diploma in Biotechnology, Bioprocess or Chemical Engineering, or similar
• Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects
• Expertise in automation and vertical integration as well as data management under validated computer systems
• Versed with planning CQV activities, leading large senior reports
• Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
• English and German spoken and written
• Excellent written and verbal communication skills

Benefits

At agap2 you will work with a Technical Manager at your side who will follow, support and prepare you for next steps in your career. In addition, you can expect work in a friendly and dynamic team, extensive development opportunities and growing responsibilities.

Applications from Switzerland and EU only will be considered.