Senior Validation Engineer
We are seeking a highly skilled Senior Validation Engineer to lead validation efforts across our clients' critical systems. The ideal candidate will have a deep understanding of 21 CFR Part 11, 21 CFR 820, and GAMP/CSA methodology.
About the Role
The Senior Validation Engineer will be responsible for leading validation and assurance efforts for IT and OT systems, including developing and executing protocols (IQ/OQ/PQ/PPQ, Test Method Validation). The role requires strong communication and documentation skills, as well as the ability to partner cross-functionally with QA, IT, Engineering, and Manufacturing teams.
Key Responsibilities
* Lead validation and Computer Software Assurance (CSA) for IT and OT systems
* Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation)
* Provide risk-based validation guidance aligned with GxP, FDA, and EU MDR requirements
* Partner cross-functionally with QA, IT, Engineering, and Manufacturing teams
* Support system and process improvements that enhance quality, compliance, and efficiency
Requirements
* 5+ years of experience in computer system validation or software assurance in a regulated environment (medical device/pharma)
* Deep knowledge of 21 CFR Part 11, 21 CFR 820, ISO 13485, and GAMP/CSA methodology
* Strong understanding of IT/OT systems (e.g., MES, SCADA, ERP, LIMS, Data Historians)
* Proven experience developing validation plans, protocols, and risk assessments
* Excellent communication and documentation skills
Bonus Points
* Experience validating manufacturing automation systems (MES, PLC, SCADA)
* ASQ Software Quality Engineer certification
* Familiarity with Six Sigma or TQM principles
What We Offer
A very competitive rate on offer.
Contact us for a confidential discussion and more information on the role.