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Open nowPosted 21 days ago

QA CSV Engineer (m/w/d)

job-room.ch86,007 open roles

Where
Basel, BS, Switzerland
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Your applicationOpen nowQA CSV Engineer (m/w/d)job-room.ch · Basel, BS, Switzerland

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This job: posted 21 days ago

The posting

Shape the future of Life Sciences with Techfirm Engineering 🚀

For our International / Consulting / Industrial Services team, Techfirm Engineering is looking for a QA CSV Engineer with a strong background in Computer System Validation (CSV) and experience in a GMP-regulated pharmaceutical, biotechnology or Life Sciences environment.

Your Mission :

As a QA CSV Engineer, you will be responsible for supporting and ensuring the quality and compliance of computerized systems throughout their lifecycle within a GMP-regulated environment.

You will work closely with Quality Assurance, IT, CSV, Engineering, Manufacturing and other business functions to ensure that computerized systems are implemented, validated and maintained in accordance with applicable GMP, GxP, Data Integrity and regulatory requirements.

Key Responsibilities :

  • Plan, coordinate and execute Computer System Validation (CSV) activities within a GMP-regulated environment.
  • Support the validation lifecycle of GxP-relevant computerized systems, from initial requirements through implementation, validation and operation.
  • Prepare, review and maintain validation documentation, including Validation Plans, URS, Risk Assessments, Functional Specifications, Test Protocols and Traceability Matrices.
  • Support and/or execute IQ/OQ/PQ testing, User Acceptance Testing and other validation activities.
  • Ensure that computerized systems are validated in accordance with GMP, GxP and internal quality standards.
  • Perform risk-based assessments and support the definition of appropriate validation strategies.
  • Ensure compliance with Data Integrity and ALCOA+ principles throughout the system lifecycle.
  • Support the management and investigation of deviations, change controls and CAPAs related to computerized systems.
  • Review and approve CSV-related documentation from a Quality Assurance perspective.
  • Support the preparation for and participation in internal and external audits and regulatory inspections.
  • Collaborate closely with IT, Quality Assurance, Engineering, Manufacturing, Quality Control, Automation and System Owners.
  • Ensure that changes to computerized systems are assessed, documented and implemented in accordance with GMP and change control requirements.
  • Contribute to the continuous improvement of CSV processes, validation strategies and quality systems.
  • Support the development and implementation of SOPs, procedures, work instructions and validation standards.
  • Provide QA/CSV expertise during projects, system implementations, upgrades and remediation activities.

Your Profile :

- Degree or professional qualification in Engineering, Life Sciences, Computer Science, Information Technology or a related technical/scientific field. - 3-5 years of professional experience in Computer System Validation (CSV). - Previous experience in a pharmaceutical, biotechnology, medical device or other GMP-regulated environment. - Solid knowledge of GMP/GxP requirements related to computerized systems. - Practical experience with CSV lifecycle processes and risk-based validation approaches. - Experience with validation documentation, including URS, risk assessments, test protocols and traceability matrices. - Good understanding of Data Integrity / ALCOA+ principles. - Experience with Deviations, Change Controls and CAPA. - Knowledge of relevant regulatory guidelines and standards related to computerized systems and CSV. - Experience with GxP-relevant systems such as MES, LIMS, SAP/ERP, SCADA, BMS or Quality Management Systems is an advantage. -Strong communication and collaboration skills. - Ability to work independently while being part of a multidisciplinary project team. - Structured, analytical and solution-oriented mindset. - Fluent in English, both written and spoken. German is an advantage, particularly for projects in German-speaking Switzerland.

What We Offer at Techfirm engineering :

Over 25 years on the market with strong knowledge of the Swiss industrial ecosystem. 100% Swiss-headquartered company with local implementation. Multicultural, human-sized environment fostering collaboration and respect. Close proximity between consultants, clients and project teams. Project selection aligned with your skills, experience and career goals. Long-term, high-value industrial projects across Life Sciences, Pharma, Biotechnology, MedTech, Energy, Transport, Construction, Chemistry and more. Opportunity to work on high-impact validation and digitalization projects within leading Life Sciences companies. Focus on well-being and professional growth. Inclusive workplace promoting diversity and equal opportunities.

📩 Ready to Join Us?

If this sounds like you, click on the apply button or contact me on LinkedIn and start your next challenge with Techfirm Engineering.

Please note: we can only consider Swiss or EU/EFTA nationals, or candidates holding a valid Swiss work or residence permit.

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