Location: Northwestern Switzerland (Basel/Berne/Neuchâtel region)
Industry: Biopharmaceuticals
Job Type: Full-Time
Contract Type: Permanent
Department: Site Engineering / Technical Operations
CK QLS are working with an established biopharmaceutical manufacturing site in Switzerland, and are seeking an experienced Plant Engineer, to join it's technical operations team. This is a critical, hands-on role, supporting complex production systems, in a highly regulated cGMP environment.
Role Summary: The Plant Engineer will serve as a subject matter expert (SME) for bulk production systems and process equipment. You will work closely with operations and quality teams to troubleshoot issues, implement upgrades, and lead continuous improvement initiatives across core production areas including bioreactors, filtration systems, chromatography, and CIP/SIP skids.
Key Responsibilities:- Act as the technical lead and primary engineering contact for designated production installations.
- Provide expert support on systems including bioreactors, UF/DF, process vessels, filtration units, chromatography skids, CIP/SIP, and process piping.
- Lead or support equipment installation, commissioning, qualification, and ongoing optimization projects.
- Identify and resolve equipment issues to maintain plant performance and compliance.
- Coordinate corrective actions, upgrades, and preventive maintenance with internal and external stakeholders.
- Ensure systems meet GMP, GEP, and local safety/regulatory standards (e.g., SUVA, ASIT).
- Participate in audits and represent systems as the SME during inspections.
- Support the site s equipment obsolescence program and technical documentation systems.
Candidate Profile:- Degree in Mechanical, Chemical, Process, or Biotech Engineering (BSc or MSc).
- 7+ years experience in the Pharma or Biotech sector (engineering, process support, or production).
- Demonstrated experience with:
- Bioreactors, process tanks, and filtration systems.
- Chromatography, CIP/SIP systems.
- Process instrumentation and piping.
- Utility systems (e.g., autoclaves, water, steam).
- Familiarity with PLC/automation systems (Siemens, Allen-Bradley) is a plus.
- Strong knowledge of cGxP, GEP, and industry guidelines (ISPE, FDA, ASTM 2500, ASME BPE).
- Fluent in French and English (written and spoken); German is advantageous.
- Skilled in MS Office, MS Project, and technical documentation.
Desired Qualities- Analytical mindset with strong problem-solving skills.
- Collaborative, team-oriented, and hands-on approach.
- Proactive, action-oriented, and comfortable working in fast-paced regulated environments.
Apply Now: This is an excellent opportunity to join a growing and innovative life sciences manufacturer that plays a vital role in global healthcare.
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.
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