QA Qualification Engineer
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Shape the Future of Industrial Technology with Techfirm Engineering
Techfirm Engineering is looking for a QA / Qualification engineer (m/d/w) to join our Industrial Services team in the German-speaking part of Switzerland. If you are passionate about commissioning, qualification, and validation in pharma/biotech environments and want to grow your expertise in high-value industrial projects, this opportunity is for you.
What You Will Do :
- Lead Commissioning, Qualification & Validation (CQV) activities for equipment, utilities, and cleanrooms: DQ/IQ/OQ/PQ protocols, FAT/SAT execution, and reporting.
- Review and approve CQV documentation including URS, risk assessments, test plans, deviations, and change controls, ensuring GMP/FDA compliance.
- Conduct risk analyses (FMEA), GAP analyses, and support CAPA/non-conformity management.
- Collaborate closely with Engineering, Operations, and vendors to ensure smooth qualification and validation of new equipment and processes.
- Contribute to continuous improvement initiatives for Quality Management Systems (QMS), SOPs, and training, with hands-on involvement in cleanroom and aseptic operations.
What We Are Looking For :
- Higher degree in Science, Engineering, Pharmacy, Biotechnology, or related field.
- Minimum 5 years of experience in CQV / Qualification / Process Engineering within pharma or biotech CAPEX projects.
- Strong knowledge of GMP, FDA regulations, ISPE Baseline Guides, GAMP 5.
- Experience with clean utilities, aseptic manufacturing, and cleanroom operations is a plus.
- Excellent technical writing, organizational, and stakeholder management skills.
- German mandatory (spoken/written); fluent English is a strong plus.
- Swiss-headquartered, multicultural environment fostering collaboration, respect, and professional growth.
- Work on high-value CAPEX projects in Life Sciences, Energy, Transport, Construction, Chemistry, and more.
- Long-term engagement with hands-on project responsibility.
- Close collaboration between consultants, clients, and project teams — your work has real impact.
- Focus on employee well-being, career development, and inclusivity.
Please note: only Swiss or EU/EFTA nationals, or candidates holding a valid Swiss work/residence permit, can be considered.
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