Validation Lead
Allendale, NJ

Job Description

Technical/Functional Skills

* Experience in Validation Engineering in FDA regulated Pharmaceutical environment with concentration in Computer System Validation (CSV)
* Design of Validation documents like Validation plan, IQ/OQ/PQ Protocols, Test cases and Traceability Matrix, Summary reports.
* Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 820 and general principles of Software Validation Life Cycle.
* Familiarity of TrakSYS application, Infrastructure Validation is a plus
* GDPR basic Knowledge

Experience Required

Seasoned quality professional (who understands both prospective/retrospective validation and QA) who can work full time on the M&A projects. This individual should be a quick learner, understand SYK QMS, work with the PMs in understanding the scope of work, proactively reach out to the POC at the acquired facility/site, Lead remediation efforts, understand the scope of work, prioritize and procure additional resources as needed.