The Qualification Engineer will execute the qualification of key upstream and downstream equipment, including bioreactors, chromatography systems, and filtration units. This role ensures our equipment complies with GMP standards, delivering high-quality, reliable performance.

Key Responsibilities

• Upstream Equipment: Qualify bioreactors, fermentation tanks, and cell culture systems through IQ, OQ, and PQ protocols.
• Downstream Equipment: Conduct qualification for chromatography systems, centrifuges, and filtration systems.
• Protocol Development: Draft, execute, and document qualification protocols in line with SOPs and regulatory standards.
• Process Validation: Validate equipment for consistent, high-quality output, troubleshooting issues as needed.
• Compliance: Maintain thorough documentation and ensure alignment with GMP, FDA, and EMA regulations.

Requirements

• Education: Bachelor’s in Engineering, Biotechnology, or related field.
• Experience: Minimum of 5 years in equipment qualification within a biopharmaceutical setting.
• Technical Knowledge: Familiar with bioreactors, filtration units, chromatography systems, and GMP standards.
• Skills: Strong problem-solving, documentation, and project management abilities.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

Greg King