Job Role Overview
We seek an experienced professional with a strong background in commissioning, qualification, and validation to join our organization. The ideal candidate will have experience in the pharmaceutical, medical device or biotechnology industries.
As a System Validation Specialist, you will be responsible for leading system validation activities across GxP-regulated systems. You will ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines, and collaborate with IT, QC, and business teams to meet user and regulatory needs.
You will develop and review system validation plans, risk assessments, and traceability matrices, contribute to data integrity programs, and support audits. You will also provide training and promote a quality-focused culture within the organization.
This is a full-time opportunity for someone looking to make a meaningful impact in a high-growth, high-integrity setting.
Required Skills and Qualifications:
* Experience in commissioning, qualification, and validation of GxP-regulated systems
* Strong understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines
* Excellent communication and collaboration skills
* Ability to work in a fast-paced environment and prioritize multiple tasks
Benefits:
* Opportunity to work in a high-growth industry
* Chance to make a meaningful impact in a quality-focused organization
* Collaborative and dynamic work environment