Senior CSV Consultant
Location: Greater Basel Area, Switzerland
Employment Type: 12-month Contract
Languages: Fluent German & English required
About the Opportunity
An international pharmaceutical manufacturer is seeking an experienced Senior Computer System Validation (CSV) Consultant to support a range of strategic digitalisation and compliance initiatives at its Basel-area operations.
This role offers the opportunity to work within a highly regulated GMP environment, partnering with Engineering, IT, Manufacturing and Quality teams to ensure the successful validation of business-critical computerised systems. You'll play a key role in maintaining regulatory compliance while supporting the implementation of new technologies across the site.
The Role
As a Senior CSV Consultant, you will lead and support Computer System Validation activities across the full system lifecycle, ensuring compliance with global regulatory standards and company quality requirements.
Key Responsibilities
Develop and execute validation strategies for GxP-regulated computerised systems.
Prepare, review and approve validation documentation, including Validation Plans, URS, Functional & Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices and Validation Summary Reports.
Lead validation activities for new system implementations, upgrades and lifecycle changes.
Act as the CSV Lead or Validation Manager on complex IT and automation projects.
Support validation across ERP, MES, Manufacturing Systems, Quality Management Systems (QMS) and Cloud-based applications.
Work closely with Business, IT, Engineering, Manufacturing and Quality Assurance to ensure compliant project delivery.
Ensure compliance with GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity (ALCOA+) principles.
Mentor junior team members and contribute to the continuous improvement of validation processes and standards.
Requirements:
Minimum of 6 years' experience in Computer System Validation (CSV/CSA), IT Validation or Compliance within the pharmaceutical, biotechnology or other GxP-regulated industries.
Strong understanding of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
Proven experience preparing and reviewing validation documentation across the full CSV lifecycle.
Experience applying risk-based validation methodologies and Data Integrity principles.
Exposure to ERP, MES, QMS or Cloud-based systems is highly desirable.
Experience working within multidisciplinary project teams in a GMP manufacturing environment.
Excellent stakeholder management and communication skills.
Fluent German and English, both written and spoken.
