Validation Engineer

Job Description:We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).Roles & Responsibilities:Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipmentEnsure compliance with GMP and 21 CFR Part 11 standardsDevelop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization proceduresConduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance monitoringPerform instrument calibration for equipment such as dual display light meters, open air shakers, and various scalesSupport validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclavesExecute validation projects, ensuring timelines, budgets, and KPIs are metCollaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepanciesApply a risk-based approach to validation to ensure compliance and operational efficiencyCoordinate resources and activities for complex validation and CSV initiativesRequirements:Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment.Strong knowledge of GMP and 21 CFR Part 11 compliance.Proven experience with Computerized System Validation (CSV).Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation.Strong problem-solving, communication, and cross-functional collaboration skills.