QA Quality Engineering (C&Q) Specialist (w/m/d)

Shape the Future of Industrial Technology

Join our Industrial Services team at Techfirm Engineering, where we are engaged in exciting challenges and valuable growth opportunities in the German-speaking part of Switzerland.

Key Responsibilities

• Review and approve C&Q documentation, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test plans, deviations, and change controls in compliance with GMP/FDA standards.
• Execute and document commissioning, qualification, and validation activities for equipment, clean utilities, and cleanrooms, overseeing FAT/SAT execution and reporting.
• Conduct risk analyses (FMEA), GAP analyses, ensure compliance with GMP (EU GMP Annex 1, FDA 21 CFR Part 210/211, ISPE Baseline Guides, GAMP 5), and manage CAPAs/non-conformities.
• Provide hands-on QA support in aseptic manufacturing, monitoring cleanroom behaviors, gowning, visual inspections, and contributing to QMS improvements (SOPs, training).

Your Background

• A higher degree in Science, Engineering, Pharmacy, Biotechnology, or a related field.
• A minimum of 5 years of relevant experience in QA/C&Q/CQV within pharmaceutical or biotech CAPEX projects.
• An ideal background in process or qualification engineering.
• Strong skills in technical writing, stakeholder management across Engineering, Operations, and vendors, as well as clean utilities/cleanroom qualification.
• Fluent German (spoken and written) is mandatory; proficiency in English is a strong advantage.
• Excellent organizational skills and a proactive mindset.

About Techfirm

With over 25 years of experience in the market, Techfirm Engineering possesses strong knowledge of the Swiss industrial ecosystem. We are a 100% Swiss-headquartered company committed to local implementation and fostering a multicultural and human-sized environment that promotes collaboration and respect. Our close proximity between consultants, clients, and project teams ensures that project selection aligns with your skills, experience, and career goals.

We focus on long-term, high-value industrial projects across various sectors, including Life Sciences, Energy, Transport, Construction, and Chemistry. Additionally, we emphasize well-being and professional growth and maintain an inclusive workplace that promotes diversity and equal opportunities.

Ready to Join Us?

If all of this resonates with you, take the next step in your career journey with Techfirm Engineering.