Advanced Medicine System Validation Lead
1 day ago
CAI is seeking an experienced System Validation Specialist to lead validation activities across GxP-regulated systems.
Job Description:The ideal candidate will have a strong background in system validation within GxP environments, with experience in commissioning, qualification, and validation of GxP-regulated systems. They will be responsible for ensuring compliance with regulatory frameworks, partnering with teams to meet user and regulatory needs, and promoting a quality-focused culture.
Key Responsibilities:- Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5.
- Partner with IT, QC, and business teams to meet user and regulatory needs.
- Author and review validation plans, risk assessments, and traceability matrices.
- Contribute to data integrity programs and support audits.
This role offers opportunities for growth and the chance to work with recognized subject matter experts in the advanced medicine space.
Requirements:- 3+ years' experience in system validation in pharma, biotech, or medical devices.
- Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks.
- Experience validating ERP, LIMS, QMS, or equipment-related software.
A collaborative culture, growth opportunities, and the chance to work with experts in advanced medicine make this a compelling opportunity for a skilled System Validation Specialist.
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