Validation Engineer

Overview As a Quality Engineer in validation, you support GMP cleaning validation and qualification of equipment, facilities, and utilities. You will collaborate with Manufacturing and Engineering to plan, execute, and document validation activities within the Quality Engineering scope. You monitor validated systems, write protocols and reports, and lead investigations to drive improvements. This role offers hands-on impact in ensuring compliant, efficient operations across API and PMO manufacturing. Compensation / Benefitscompetitive payannual performance bonusmedical/dental/vision coverage401(k) plan with employer contributionpaid vacationpersonal and sick days ResponsibilitiesDevelop strategy and acceptance criteria for cleaning validation; generate and execute protocols and reportsLead cross-functional teams to ensure on-time qualification/validation deliverablesProvide validation guidance during project planning and developmentWrite validation protocols, test methods, SOPs, and technical reportsPlan, write, and execute DQ/IQ/OQ/PQ documentation and related reportsConduct investigations related to validation studies and document findingsEvaluate validation results and recommend process improvementsSupport inspections and audits; perform periodic re-validation/re-qualificationCommunicate across stakeholders to ensure timely task completionAdhere to cGMP and safety procedures; contribute to GMP system improvements Key requirements5+ years CQV/cleaning validation experience in GMP/GDP environmentExperience planning, writing, and executing IQ/OQ/PQ protocols and reportsExperience validating critical pharma utility systems ( purified water, nitrogen, cold storage)Experience with cleaning validation of production lab glassware and equipment; creating validation studies and reportsExperience with coupon spike and recovery studies for cleaning validationKnowledge of Lean Six Sigma methods (root cause, FMEA)Understanding of cleaning validation requirements for pharmaceutical industryKnowledge of MAC calculation for APIsUnderstanding of GMP for Active Pharmaceutical Ingredients per ICH Q7Mid or large-size CapEx project experienceGeneral lab instrumentation knowledge and operationCapable of methodical work and regulatory complianceCross-functional collaborationMentoring and coachingProblem solving and analytical thinkingCleaning validation and CQVIQ/OQ/PQ protocol development and executionValidation of utility systems ( purified water, nitrogen, cold storage)