Senior Computer System Validation (CSV) Engineer | CSA | Pharma
Senior Computer Software Assurance (CSA) Engineer
Bilthoven, Netherlands | Hybrid (Minimum 3 days on-site) | Permanent
Salary: €4,145 – €6,339 gross per month + 13th month + excellent pension & benefits
Language: Dutch required
Role: Our client, an international pharmaceutical manufacturer, is looking for an experienced Senior Computer Software Assurance (CSA) Engineer to join their Information Management team. You will play a key role in ensuring business-critical GxP systems remain compliant throughout their lifecycle while supporting digital transformation and computerised system validation across the business.
Key Responsibilities
- Develop and maintain risk-based Computer Software Assurance (CSA) strategies.
- Review and approve validation documentation, risk assessments, change controls, and validation reports.
- Support application teams with validation and testing strategies.
- Ensure compliance with GAMP 5, Annex 11, GMP, and ALCOA+ Data Integrity principles.
- Support internal and external audits and regulatory inspections.
- Act as the Subject Matter Expert (SME) for CSA, CSV, and computerized system compliance.
Required Experience
- 5+ years' experience in Computer Software Assurance (CSA), Computer System Validation (CSV), IT Quality, or Validation Engineering within a GMP/GxP-regulated pharmaceutical, biotechnology, vaccine, or medical device environment.
- Experience validating GxP-regulated enterprise applications.
- Experience with one or more of the following systems:
- SAP
- MES / PharmaSuite
- LIMS / LabVantage
- Veeva
- QMS
- Knowledge of:
- Computer Software Assurance (CSA)
- Computer System Validation (CSV)
- GAMP 5
- EU GMP Annex 11
- Data Integrity (ALCOA+)
- Change Control
- Validation Lifecycle Documentation
- Software Development Lifecycle (SDLC)
- Experience supporting GMP audits and regulatory inspections.
Preferred Experience
- Experience with Werum PAS-X or other Manufacturing Execution Systems.
- Experience with Agile and DevOps environments.
- Knowledge of EU GMP Annex 1 and NIS2.
- Experience developing validation strategies and risk-based CSA approaches.
- Experience acting as a Subject Matter Expert (SME) for computerized systems.
- Experience mentoring validation engineers or leading validation activities.
What's on Offer
- Permanent opportunity with an international pharmaceutical manufacturer.
- Hybrid working (minimum 3 days on-site).
- Salary €4,145 – €6,339 gross per month (depending on experience).
- 13th-month salary.
- Excellent pension scheme and benefits.
- Opportunity to play a key role in the digital transformation of a highly regulated pharmaceutical environment.
Interested? Apply directly or send your CV to [email protected]
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