Commissioning & Qualification Engineer (m/f/d)

Commissioning & Qualification Engineer (m/f/d)

Shape the Future of Pharma Your Expertise in Qualification & Validation Is Needed Now!

• ? Duration: ASAP – approx. 5 months (temporary assignment)
• ? Location: Basel, Switzerland
• ? Employment Type: Temporary

About Our Client

For this assignment, we are partnering with a globally active company in the pharmaceutical and life sciences sector an industry leader renowned for its high standards in GMP compliance, cutting-edge manufacturing technologies, and a strong culture of quality and continuous improvement. As part of their Technology Lifecycle Excellence team, you will be at the heart of complex qualification and validation projects that directly impact product safety and regulatory readiness.

Your Responsibilities

As Commissioning & Qualification Engineer (m/f/d), you will take on a central role in ensuring GMP compliance across the site:

• Lead and coordinate qualification and cleaning/sterilization validation projects, aligning with cross-functional teams and network colleagues to implement best practices
• Develop, review, and improve critical GMP documentation including SOPs, qualification/validation protocols, and technical reports
• Act as Subject Matter Expert (SME) for qualification and cleaning/sterilization validation topics across the entire site
• Represent the TLE function in local and global cross-functional meetings as well as during regulatory inspections
• Drive process improvements by identifying and harmonizing qualification practices site-wide, reducing implementation effort while maintaining full compliance
• Evaluate innovative equipment and technologies with regard to qualification and CSV requirements, including assessment of user requirements
• Manage deviations and change controls, conducting root cause investigations and ensuring timely resolution

Your Profile

We are looking for a driven and experienced specialist who brings the following:

• University degree in Engineering, Biotechnology, Biology, Microbiology, or a related field
• Minimum 5 years of experience in a pharmaceutical environment, including at least 2 years in computer system validation (CSV), equipment qualification, and/or cleaning validation
• Strong GMP knowledge and solid understanding of current regulatory standards and industrial guidelines
• Proven track record in auditing, compliance management, and change/deviation handling
• Excellent project management skills ability to prioritize, allocate resources effectively, and deliver results on time
• Strong communication abilities capable of presenting complex topics clearly and persuasively across all organizational levels
• Fluent English skills (written and spoken); additional languages are a plus

Why nemensis?

• Nemensis AG is your specialized recruitment partner in the Life Sciences sector, headquartered in Basel.
• Comprehensive guidance and support throughout the entire application process by our experienced Consultants.
• Access to an extensive client network and exciting opportunities across Northwestern Switzerland.
• Fast and straightforward onboarding through personalized coaching and individual support at every step of the process.

Ready to Make Your Mark?

At nemensis ag, we have successfully connected thousands of candidates with their ideal roles opening doors to new challenges and career growth. Are you the Commissioning & Qualification Engineer (m/f/d) we're looking for in the Basel area? We'd love to hear from you reach out today and let's talk about your next step!

? Phill Rogers, Consultant Write an email

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