QA Qualification Engineer - German speaking (m/w/d)

TechFirm Engineering; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Techfirm Engineering in Basel is seeking a QA / Qualification engineer to lead CQV activities for equipment, utilities and cleanrooms in pharma/biotech projects.

You will review URS, risk assessments, test plans, deviations and change controls, and ensure GMP/FDA compliance while collaborating with Engineering, Operations and vendors.

German language is mandatory; fluent English is a strong plus, and the role offers long-term engagement in a multicultural, Swiss-headquartered environment.

Qualifikationen

• Minimum 5 years of experience in CQV/Qualification/Process Engineering in pharma/biotech CAPEX projects.
• Strong knowledge of GMP, FDA regulations, ISPE Baseline Guides, GAMP 5.
• German mandatory; fluent English is a strong plus.
• Experience with clean utilities, aseptic manufacturing and cleanroom operations is a plus.
• Excellent technical writing, organizational and stakeholder management skills.

Aufgaben

• Lead Commissioning, Qualification & Validation (CQV) activities for equipment, utilities and cleanrooms.
• Review and approve CQV documentation including URS, risk assessments, test plans, deviations and change controls.
• Conduct risk analyses (FMEA) and support CAPA/non-conformity management.
• Collaborate with Engineering, Operations and vendors to qualify and validate new equipment/processes.
• Contribute to QMS, SOPs and training with hands-on involvement in cleanroom operations.

Kenntnisse

CQV

GMP compliance

FMEA risk analysis

Technical writing

Stakeholder management

German language

Project collaboration

Ausbildung

Master's degree in Science/Engineering

Jobbeschreibung

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.