Project Manager Utilities Expert

Vor 4 Tagen

Bern, Bern, Schweiz EFOR Vollzeit

In 12 years,
the Efor Group
has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. Our ambition is to build a global leading position of our market in
2028.

In Switzerland, we work with
300 experts
who support our customers on their various projects in the French and German-speaking parts. With our three agencies in
Geneva, Lausanne and Basel,
we help our customers to diversify and grow through the work of our consultants and the technical expertise our
Technical Department.

To strengthen our team, we are looking for a
Project Manager Utilities Expert (M/F/X).

ABOUT THE JOB:

  • Develop and execute qualification protocols (IQ, OQ, PQ) for utility systems in compliance with regulatory guidelines (e.g., FDA, EU GMP).
  • Provide field support for the commissioning and qualification of the following utility and process systems.
  • Black and Clean Utility generation, storage and distribution systems;
  • Heating Ventilation and Air Conditioning for the classified and non-classified areas within the site manufacturing and utility areas.
  • Environmental Monitoring System.
  • Compounding and SIP/CIP system.
  • Other systems as required.
  • Perform risk assessments, gap analyses, and validation plans ensuring equipment is fully compliant.
  • Support calibration activities and ensure instruments are within specified ranges.
  • Collaborate with cross-functional teams (Engineering, Production, QA, QC) on new equipment installations, upgrades, and system optimizations.
  • Provide technical expertise during equipment design and commissioning phases.
  • Prepare detailed validation documentation, including protocols, summary reports, deviations, and corrective actions.
  • Ensure all documentation aligns with company SOPs, quality standards, and regulatory requirements.
  • Conduct periodic reviews and preventive maintenance validation of utilties.
  • Assist with troubleshooting and root cause analysis for equipment performance issues.
  • Stay updated on evolving regulatory standards and technological advancements in utility systems.

ABOUT YOU:

  • Bachelor's degree in Mechanical, Chemical, or Pharmaceutical Engineering, or a related field.
  • Minimum 5 years of experience in qualification/validation within the pharmaceutical industry, with a focus on lyophilization and utility systems.
  • Strong knowledge of GMP, FDA guidelines, ICH Q8-Q10, and validation requirements.
  • Hands-on experience in equipment qualification, including thermal mapping and control system validation.
  • Proficiency with validation tools (pressure meters, particle counters, temperature probes, etc.).

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

Do you want to join a dynamic and ambitious company? EFOR is made for you. Send your application to : kathleen.-

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