Principal Validation Engineer
Position Summary
The Principal Validation & Compliance Engineer oversees validation activities for equipment, systems, processes, and software within regulated environments (pharma, biotech, medical devices, manufacturing, etc.). This role ensures compliance to GxP, FDA, ISO, and industry standards while leading validation strategy and governance.
Key Responsibilities
Lead validation lifecycle activities: IQ, OQ, PQ, CSV, process validation, equipment qualification.Develop validation master plans, protocols, risk assessments, and reports.Ensure regulatory compliance with FDA 21 CFR Part 11, GAMP 5, ISO 13485, and other standards.Partner with engineering, manufacturing, QA/QC, and operations teams to ensure validated state.Perform gap assessments, audits, and remediation of validation documentation.Oversee change control processes, deviation handling, CAPA investigations, and continuous improvement.Manage validation projects from planning through execution and closure.Evaluate and qualify new equipment, instrumentation, and software systems.Serve as SME during regulatory inspections and customer audits.
Required Skills & Experience
10–15 years of experience in validation engineering within regulated industries.Strong expertise in Computer System Validation (CSV) and equipment/process validation.Hands-on experience with IQ/OQ/PQ, URS/FDS, risk management (FMEA), and validation documentation.Deep knowledge of GxP regulations and regulatory agency expectations.Experience working with QMS systems and electronic documentation platforms.Excellent documentation, technical writing, and cross-functional communication skills.
Preferred Qualifications
Certifications: ASQ CQA/CQE, Six Sigma Green Belt/Black Belt, or similar.Experience in automation systems (PLC/SCADA), MES, LIMS, or ERP validation.Experience supporting FDA/EMA audits and customer quality audits.