CSV Engineer

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• Location: Basel, Basel-City Switzerland
• Position: CSV engineer
• Sector: Life Science
• Type of contract: Permanent
• Starting date: ASAP

Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in industry. We operate in the Pharmaceutical, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will support our clients in the successful execution of their projects by providing your technical expertise and engineering know-how.

You are adaptable, proactive, and motivated to work in diverse industrial environments, contributing to high-impact engineering projects for leading international companies.

Your main missions are:

Plan & define validation of computerized systems

• Develop validation plans, strategies and risk assessments for GxP computerized systems (MES, LIMS, SCADA/DCS, BMS/EMS, ERP, QMS, laboratory and equipment software)
• Review and approve user requirements (URS), functional and design specifications (FS/DS) and configuration documents
• Define the validation approach based on GAMP 5 (2nd edition) and the risk-based Computer Software Assurance (CSA) principles
• Assess suppliers and review vendor documentation, including supplier audits where required

Execute & approve qualification and testing

• Prepare, execute and approve test documentation (IQ, OQ, PQ, UAT) and the traceability matrix
• Supervise vendor testing (FAT/SAT) for scope, quality and documentation
• Manage test deviations, defect resolution and release for operational use
• Prepare validation summary reports and ensure systems are inspection-ready

Ensure compliance & data integrity

• Ensure compliance with EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+ data integrity principles
• Define and verify controls for user access management, audit trails, electronic signatures, backup/restore and disaster recovery
• Contribute to cybersecurity and periodic review activities for validated systems
• Maintain the validated state through change control, periodic reviews and decommissioning

Keep the project on track

• Report on key deliverables and milestones in line with the project’s critical path
• Handle deviations and CAPAs, and maintain non-conformance records
• Contribute to risk assessments (FMEA) and evaluate the effectiveness of mitigation measures
• Coordinate with IT, automation, quality, vendors and business stakeholders on site

This job is made for you if...

• A Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering or a related field
• At least 3 years of experience in Computer System Validation in a pharmaceutical or biotech environment
• Solid knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and data integrity requirements
• Hands-on experience in writing and executing validation documents (VP, URS, FS, IQ/OQ/PQ, RTM, VSR)
• Experience with risk-based approaches (ICH Q9, CSA)
• Understanding of automation and IT infrastructure (PLC, SCADA, networks, servers, virtualization) is a clear advantage
• Independent, structured and solution-oriented working style with excellent communication skills
• Fluent English and German

Working with us means...

• Joining a group with strong development potential that aims to improve your employability on challenging and varied projects.
• Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector.
• Having a sustainable job with stability and access to a real collaboration.
• Benefit from training with accredited and certified centers.
• Having a local management team to support you in the achievement of your missions and in the development of your career.
• Being part of a dynamic, committed team with real human values that we live by every day.

Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.