Qualification / CSV Engineer

For one of our clients, an international pharmaceutical company, we are seeking a Qualification/Computer System Validation Engineer. General Information: - Start date: 01.12.2026 - End Date: 30.11.2027 - Workplace: Schachen, Luzern - Workload: 100% - Working hours: Standard - Home Office: primarily onsite We are seeking a motivated and detail-oriented Qualification / Computer System Validation Engineer to support qualification and validation activities within a pharmaceutical environment. The ideal candidate will have strong experience in equipment, utility, and clean room system qualification, as well as computer system validation in a GMP-regulated environment.

- Manage qualification and validation activities for Lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities. - Prepare, review, and execute qualification and validation documentations, including protocols, reports, and assessments. - Provide oversight for computer system validation activities in manufacturing and quality environments. - Ensure all activities are performed in compliance with cGMP, regulatory requirements, and company standards. - Collaborate with cross-functional teams including Production, QC, and Engineering. - Support internal and external audits, inspections, and quality improvement initiatives. - Review GMP-related documents as required (e.g. Technical assessments, Deviations, CAPAs, Change Controls). - Contribute to continuous improvement of qualification and validation processes. Required Qualifications: - Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline. - Minimum 5 years of experience in Qualification/Validation. - Strong working knowledge of GMP / cGMP principles and practices. - Hands-on experience in: - Qualification / Validation activities, - Computer System Validation - Good understanding of regulatory expectations and quality systems in the GMP area. - Strong analytical, problem-solving, and documentation skills. - Ability to work independently and collaboratively in a fast-paced environment. - English and German language proficiency at B1 level required. Preferred Skills: - Experience in audit support and inspection readiness. - Experience in GAMP5, Annex 11 and Annex 15 - Familiarity with data integrity requirements. - Good communication and stakeholder management skills. - Proficiency in MS Office tools and quality documentation systems (VeevaVault, Kneat). Key Competencies: - Attention to detail - Strong ownership and accountability - Effective communication - Problem solving and root cause analysis - Compliance mindset - Cross-functional teamwork Sounds interesting? Apply now – we’re looking forward to receiving your applications! working at null