QA Cleaning Validation Engineer (m/d/w)

Shape the Future of Pharma Quality with Techfirm Engineering 🇨🇭

Techfirm Engineering is looking for a QA Cleaning Validation Engineer (m/d/w) to join our Industrial Services team in the German-speaking part of Switzerland.

If you are passionate about cleaning validation, GMP compliance, and QA activities in pharma/biotech environments, and want to grow your expertise in high-value regulated industrial projects, this opportunity is for you.

What You Will Do:

• Lead and support Cleaning Validation activities for manufacturing equipment and processes in GMP environments.

• Develop, review, and execute Cleaning Validation protocols and reports (including validation strategy, risk assessments, and sampling plans).

• Define and justify acceptance criteria (MACO, HBEL, carryover limits) in compliance with GMP/FDA requirements.

• Perform risk assessments (FMEA) and contribute to change control and deviation investigations related to cleaning processes.

• Support and review CIP/SIP system validation and qualification activities where applicable.

• Collaborate closely with QA, Production, Engineering, and QC teams to ensure robust contamination control strategies.

• Ensure full compliance with EU GMP Annex 15, FDA guidelines, and internal quality standards.

What We Are Looking For:

• Degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering or related field.

• Minimum 3–5 years of experience in Cleaning Validation / QA Validation within pharma or biotech environments.

• Strong knowledge of GMP regulations (EU/FDA).

• Experience with CIP/SIP systems and/or equipment qualification is a strong plus.

• Ability to write and review technical GMP documentation (protocols, reports, deviations, CAPAs).

• Strong analytical mindset and structured working approach.

• German mandatory (spoken and written); fluent English is a plus.

• Hands-on, proactive personality with strong communication skills.

Why Techfirm?

• Swiss-headquartered, multicultural environment fostering collaboration, respect, and professional growth.

• Work on high-impact projects in leading pharma and biotech companies in Switzerland.

• Exposure to complex GMP manufacturing environments and cutting-edge technologies.

• Long-term engagement with real project ownership and responsibility.

• Strong focus on career development, learning, and employee well-being.

📩 Ready to Join Us?

If this sounds like your next challenge, click “Apply” or contact me on LinkedIn to start your journey with Techfirm Engineering.

Please note: only Swiss or EU/EFTA nationals, or candidates holding a valid Swiss work/residence permit, can be considered.