Shape the Future of Industrial Technology with Techfirm Engineering
Techfirm Engineering is seeking a QA Quality Engineering (C&Q) Specialist to join our Industrial Services team in the German-speaking part of Switzerland. This is an exciting opportunity for individuals ready to tackle challenges and grow within a dynamic organization.
Key Responsibilities
- Review and approve C&Q documentation, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test plans, deviations, and change controls according to GMP/FDA standards.
- Execute and document commissioning, qualification, and validation activities for equipment, clean utilities, and cleanrooms, including FAT/SAT execution and reporting.
- Conduct risk analyses (FMEA), GAP analyses, ensure GMP compliance (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: monitor cleanroom behaviors, gowning, visual inspections, and contribute 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 pharma/biotech CAPEX projects.
- A background as a process or qualification engineer is preferred.
- Proficient in technical writing, stakeholder management (Engineering, Operations, vendors), and clean utilities/cleanroom qualification.
- Fluent in German (spoken and written); fluency in English is a strong plus.
- Excellent organizational skills and a proactive mindset.
About Techfirm
With over 25 years in the market, Techfirm Engineering possesses a strong understanding of the Swiss industrial ecosystem. We are a 100% Swiss-headquartered company committed to local implementation. Our multicultural, human-sized environment fosters collaboration and respect, ensuring close proximity between consultants, clients, and project teams.
We align project selection with your skills, experience, and career goals, focusing on long-term, high-value industrial projects across various sectors including Life Sciences, Energy, Transport, Construction, and Chemistry. We prioritize your well-being and professional growth while promoting diversity and equal opportunities in our inclusive workplace.
Ready to Join Us?
If this opportunity resonates with you, apply online using the form below. Please note that only applications matching the job profile will be considered.