QA CSV Engineer / QA CSV Engineeress

Shape the Future of Life Sciences with Techfirm Engineering

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

Your Mission

As a QA CSV Engineer, you will support and ensure the quality and compliance of computerized systems throughout their lifecycle within a GMP-regulated environment. You will collaborate closely with Quality Assurance, IT, CSV, Engineering, Manufacturing, and other business functions to guarantee that computerized systems are implemented, validated, and maintained according to 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 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.
• Manage and investigate deviations, change controls, and CAPAs related to computerized systems.
• Review and approve CSV-related documentation from a Quality Assurance perspective.
• Prepare for and participate 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 according to 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. Proficiency in German is an advantage, particularly for projects in German-speaking Switzerland.

What We Offer at Techfirm Engineering

• Over 25 years in the market with extensive 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, apply online using the form below. Please note that only applications matching the job profile will be considered.

We can only consider candidates who are Swiss or EU/EFTA nationals, or those holding a valid Swiss work or residence permit.