Senior Validation Specialist
Location:
Role:
- Industry: Technology
- Job Type: Contract / Freelance
Application Details:
- Date Posted:
Senior Validation Specialist
g2 are looking for a a Computer System Validation (CSV) Engineer with a strong IT background to support the validation and compliance of GxP-regulated IT systems within our pharmaceutical operations for my customer based in Brussels. This role will be responsible for ensuring that all computerized systems used in GxP activities meet regulatory requirements (such as 21 CFR Part 11, EU Annex 11, and GAMP 5), are properly validated, and maintain a validated state throughout their lifecycle.
Required skills:
- 3+ years of experience in CSV or IT compliance within the pharmaceutical, biotechnology, or medical device industry.
- Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Experience validating IT systems such as:
LIMS, QMS, DMS (e.g., Veeva, MasterControl)
ERP systems (e.g., SAP)
Clinical trial or manufacturing systems
- Excellent documentation and technical writing skills.
- Strong communication and stakeholder management skills.
The perfect candidate has a blend of knowledge within IT but also possess both Lab and automation knowledge.
Language:
English - Required
French - Nice to have
g2 Recruitment are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.