CSV Consultant

We are looking for a CSV Engineer to join our teams in Visp, Switzerland and support the validation and lifecycle management of computerized systems across multiple departments in a regulated (GxP) biotech environment.

Your Responsibilities

• Plan, coordinate, and execute Computer System Validation (CSV) activities for GxP-regulated systems across various departments, including Manufacturing, Quality Control, Quality Assurance, Engineering, IT, Automation, MES, and Laboratories.
• Author and review validation documentation, such as Validation Plans, Risk Assessments, URS, FS, IQ, OQ, PQ, and Validation Reports, in alignment with corporate and regulatory standards.
• Ensure that computerized systems comply with global regulatory requirements, such as EU Annex 11, FDA 21 CFR Part 11, GAMP 5, and internal quality procedures.
• Support the implementation, upgrade, and decommissioning of systems (e.g., LIMS, MES, DCS, SCADA, PLCs, ERP, Track & Trace, and IT infrastructure).
• Collaborate closely with system owners, QA, IT, and engineering teams to ensure proper design, testing, and documentation throughout the system life cycle.
• Provide CSV expertise and guidance during internal and external audits and inspections.
• Support data integrity assessments, system periodic reviews, and validation status maintenance.
• Participate in change control management, ensuring that system changes are properly assessed, tested, and documented.
• Contribute to the development and improvement of CSV policies, procedures, templates, and training materials.
• Act as a subject matter expert (SME) in computerized system compliance, advising cross-functional teams on validation strategies and risk-based approaches.

Your Profile

• Degree in Engineering, Computer Science, Life Sciences, or a related field.
• Professional experience in a regulated biotech or pharmaceutical environment, preferably in Computer System Validation (CSV), Automation, or IT Quality Compliance.
• Strong understanding of GxP principles and applicable guidelines (GAMP 5, EU Annex 11, FDA 21 CFR Part 11, Data Integrity).
• Knowledge of software development lifecycle (SDLC) and system lifecycle management (SLC) principles.
• Experience with GxP-relevant systems, such as MES, LIMS, DCS, SCADA, PLC, ERP, QMS, and laboratory informatics systems.
• Excellent analytical, documentation, and organizational skills, with a detail-oriented and structured approach.
• Strong interpersonal and communication skills, able to work effectively in a cross-functional and international team.
• Proficient in Microsoft Office and validation tools; knowledge of electronic documentation management systems (DMS), TrackWise, SAP, or similar platforms is a plus.
• Fluent in English, with German and/or French as an advantage.