CSV Engineer

CSV Engineer, Largest bio-pharmaceutical projects in Europe, Zurich

Our bio-tech client headquartered in Switzerland is currently investing significantly to their manufacturing programme.  This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. With over 2000 employees onsite, the site is easily reachable by two major airports and has excellent transport links throughout.

The client is currently seeking the expertise of a CSV Engineer to join the team on an initial 6-month contract.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

• Oversee and perform computer system validation activities ensuring the approach and execution aligns to the clients’ directives and procedures.
• Provide input on improvement of testing documentation.
• Support the implementation and adoption of the global CSV program and remediation.
• Support data integrity implementation and remediation for systems within the CSV program.
• Participate in audits and continuous improvement efforts related to CSV program.
• Support the organization to achieve all CSV site and corporate goals.

Desirable Experience:

• Ability to complete tasks with limited oversight.
• Understanding of regulations governing computer systems and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance.
• Understanding of modern and risk-based validation executions.
• Background in Life Sciences and/or Pharma/Bio-tech industries (or understanding of bio-processing and support processes).
• Direct experience with IT and MFG automation systems supporting GMP manufacturing.

Interested initially and keen to get the ball rolling? Apply now for immediate consideration and further information.




The candidate must have the rights to work in the location stated in the job advert.

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