Shape the Future of Industrial Technology with Techfirm Engineering
For our Industrial Services team, Techfirm Engineering is seeking a QA Quality Engineering (C&Q) Specialist eager to embrace exciting challenges and grow with us in the German-speaking part of Switzerland.
Key Responsibilities
- Review and approve C&Q documentation, including User Requirement Specifications (URS), risk assessments, DQ/IQ/OQ/PQ protocols, test plans, deviations, and change controls in accordance with 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.
- An ideal background as a process or qualification engineer.
- Expertise in technical writing, stakeholder management (Engineering, Operations, vendors), and clean utilities/cleanroom qualification.
- Fluency in German (spoken and written) is mandatory; English proficiency is a strong plus.
- Excellent organizational skills and a proactive mindset.
About Techfirm
- Over 25 years of market presence with a deep understanding of the Swiss industrial ecosystem.
- 100% Swiss-headquartered company dedicated to local implementation.
- A multicultural, human-sized environment fostering collaboration and respect, with close proximity between consultants, clients, and project teams.
- Project selection aligned with your skills, experience, and career goals.
- Engagement in long-term, high-value industrial projects across Life Sciences, Energy, Transport, Construction, Chemistry, and more.
- A focus on well-being and professional growth within an inclusive workplace that promotes diversity and equal opportunities.
Ready to Join Us?
If all of this resonates with you, apply online using the form below. Please note that only applications matching the job profile will be considered.