Project Utilities Expert

vor 2 Wochen

Basel, 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.

Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: _**Commitment, Excellence and Sharing.**_

In Switzerland, we work with 300 experts who support our customers on their various projects in the French
- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our **Solution & Project Delivery Department.**

To strengthen our team in the **German part of Switzerland**, we are looking for **Project 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 utilities.
- 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.).

**EFOR Group’s legal entity, KALIPSIA AG** is based at **Holbeinstr. 50, 4051 Basel**, is recruiting and managing client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates.

**Do you want to join a dynamic and ambitious company? EFOR is made for you.**

**Job Type**: 100%

Work Location: In person

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