Job Title
Senior Computer Software Assurance (CSA) Engineer (also suitable for candidates with titles such as Senior CSV Engineer, Computer System Validation Engineer, IT Quality Engineer, Quality Systems Engineer or CSA Engineer).
Description
Bilthoven Biologicals is looking for a Senior Computer Software Assurance (CSA) Engineer to support the validation, compliance, and lifecycle management of GxP-regulated computerized systems. Working within the Information Management team, you will ensure business-critical applications remain compliant with regulatory requirements while supporting digital transformation initiatives across manufacturing and quality systems.
Sectors
- Pharmaceuticals
- Biotechnology
- Vaccine Manufacturing
- Life Sciences
Company Size & Type
International pharmaceutical manufacturer specialising in vaccine development and manufacturing.
Non-Negotiable Requirements
- Experience as a Computer Software Assurance (CSA) Engineer, Computer System Validation (CSV) Engineer, IT Quality Engineer, Quality Systems Engineer, Validation Engineer, or similar role.
- Experience working within a GMP/GxP-regulated pharmaceutical, biotechnology, vaccine, CDMO, or medical device environment.
- Experience with Computer Software Assurance (CSA) and/or Computer System Validation (CSV).
- Experience validating GxP-regulated enterprise applications.
- Experience with one or more of the following systems:
- SAP
- PharmaSuite (MES)
- LabVantage (LIMS)
- Veeva
- MES
- LIMS
- QMS
- Knowledge of:
- GAMP 5
- EU GMP Annex 11
- GMP
- Data Integrity (ALCOA+)
- Experience with validation lifecycle documentation, including risk assessments, validation plans, testing, and validation reports.
- Experience supporting audits and/or regulatory inspections.
- Experience working with Change Control and Software Development Lifecycle (SDLC) processes.
Desirable Requirements
- Experience with bespoke/custom-developed GxP systems.
- Knowledge of EU GMP Annex 1.
- Knowledge of NIS2.
- Experience with Agile and DevOps methodologies.
- Experience with AFAS.
- Experience acting as a Subject Matter Expert (SME) for computerized systems.
- Experience developing validation strategies or risk-based CSA approaches.
- Experience working closely with QA, Application Managers, Business Analysts, and Manufacturing teams.
- Experience mentoring or supporting junior validation engineers.
Responsibilities
- Develop and maintain Computer Software Assurance (CSA) strategies for GxP-regulated systems.
- Ensure computerized systems remain compliant throughout their lifecycle.
- Perform risk assessments focused on patient safety, product quality, and data integrity.
- Review and approve validation documentation, including validation plans, risk assessments, test documentation, and validation reports.
- Support application teams with validation strategies and compliant testing approaches.
- Review software releases, system changes, and configurations from a compliance perspective.
- Ensure compliance with Data Integrity (ALCOA+) principles.
- Support internal and external audits and regulatory inspections.
- Support the Test Manager with validation planning and execution.
- Act as the subject matter expert for CSA, CSV, and computerized system compliance.
- Provide compliance guidance to Information Management, Quality Assurance, and business stakeholders.
- Support the validation and compliance of business-critical applications, including SAP, PharmaSuite, LabVantage, Veeva, MES, LIMS, and other GxP-regulated systems.