Validation Engineer

Overview In this CQV-focused role, you support commissioning, qualification and validation activities for API-biopharma operations, with an emphasis on cleaning validation. You will work across engineering, facilities, QA/QC and IT to ensure compliant, timely validation deliverables. You’ll drive improvements to keep the program aligned with regulatory expectations. The position offers exposure to oligonucleotide therapeutics in a fast-paced manufacturing environment and collaboration with cross-functional teams. This is a chance to help shape validation standards and support client-quality objectives. Compensation / Benefitsbonus eligibilitystock optionsbenefits package ResponsibilitiesCreate and review validation documents (plans, protocols, reports) ensuring cGMP complianceExecute and support validation studies across multiple functions (ENG, FAC, MFG, PD, QC, QA, IT)Manage or assist the validation program and implement improvementsDevelop validation scope for equipment, instruments, facilities, utilities, cleaning, and computerized systemsPrepare and approve validation documentation for IQ/OQ/PQ, SAT and cleaning phasesSupport periodic data generation for review/monitoring programsParticipate in acceptance testing for new equipment and facility qualification of classified environmentsCoordinate cleaning validation activities (sprayball testing, cycle development, surface sampling, method validations) Key requirementsBachelor's degree in engineering or life sciences1+ years of relevant experienceStrong quality orientation, communication skills, and attention to detailKnowledge of FDA/ICH regulations (21 CFR, ICH Q7) and cGMPExperience with validation programs, CAPA, and change controlAbility to work in a fast-paced, cross-functional teamstrong communicationteam collaborationattention to detailvalidation planning and executioncGMP regulatory knowledge (FDA, ICH, GAMP)IQ/OQ/PQ, SAT and commissioning processes