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.