CQV Engineer

CQV Engineer - Contract - Switzerland - World Leading Biopharmaceutical 

Our client, one of the world’s leading biotechnology companies, is currently looking for an experienced
CQV Engineer to join the Engineering team and to support the CQV project work on their new 
state-of-the-art Biotech production facility located near Bern in Switzerland :


Responsibilities:

You will be working with people coming from different departments and areas and  the main task is to execute the assigned commissioning, qualification and validation tasks according to the schedule to ensure that the area of responsibility will be ready for PPQ.

• Leading/Participating as team member of an integrated area -specific work team with key emphasis on execution and documentation of Commissioning/Qualification/validation (CQV)tests.
• Supporting the coordination of the integrated CQV Team area team (participants from different departments, vendors, etc.)
• Mitigation, follow-up, close out and verification of open/closed issues, punch items and non-conformities etc.
• General execution of CQV and DCS/MES software shake-down activities, including EMs, phases, operations, procedures and recipies.
• Review and update of functional specifications, including EMs, phases, operations, procedures and recipes, DeltaV graphics and other software components.
• Understanding and applying industry specific compliance standards/regulations to all CQV activities.
• Leading of risk assessments, root cause analysis, investigations and facilitate/support implementation of corrective and preventive actions.
• Generation and execution of commissioning test protocols, reports, project change controls and deviations using KNEAT system.
• Proactively highlighting any issues around compliance.
• Participating in internal and external audits and inspections if required.

Requirements:

• Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 7 – 10 years)
• Minimum educational level necessary to perform the job (High   School diploma, Associate’s Degree, Bachelor’s Degree, Masters, PhD) - Technical diploma or Degree in Engineering/Life Sciences or greater preferred

This is a great opportunity to work for a company which is one of the pioneers in biotechnology, led by world-class research and development, advances the latest science and leading-edge technologies to create, commercialize, and manufacture transformative therapies for patients with few or no treatment options.

To apply or for further information get in touch today!





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