Validation Engineer

The Validation Engineer will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams. The Validation Engineer will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects. Key Responsibilities Validation Documentation & Execution Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria developmentEstablish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirementsExecute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systemsReview and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements Project & Program Management Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report reviewManage external vendors and contractors performing qualification activitiesServe as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projectsDevelop and maintain validation project timelines and deliverables Compliance & Change Control Review proposed changes to validated systems and provide impact assessmentsIdentify validation requirements necessary to maintain systems in a validated state following change implementationManage periodic requalification activities to ensure equipment, utilities, and processes remain compliantSupport equipment and building monitoring systems compliance and updates Technical Expertise Serve as Subject Matter Expert (SME) in one or more of the following disciplines:Process MappingQuality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation)Equipment qualification (autoclaves, controlled temperature units, filling equipment)Cleaning validation Aseptic process simulation (media fills)Computer system validation (CSV)Process validation Utility qualification (WFI, purified water, clean steam, HVAC)Environmental monitoring systems Provide technical guidance and troubleshooting support for equipment and system failuresDeliver training on validation program elements to junior validation personnel Quality Systems Support Author and support equipment and process-related deviation investigations and CAPA activitiesPerform and support risk assessments (FMEA, etc.) and data integrity assessmentsSupport internal audits and regulatory agency inspectionsEnsure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures Qualifications Education Bachelor's degree in Engineering, Life Sciences, or related scientific discipline requiredMaster's degree (MS/MSc) preferred Experience Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environmentMinimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environmentDemonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplinesExperience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipmentExperience supporting regulatory inspections (FDA, EMA, or equivalent) preferredCapital project experience including equipment design, selection, and commissioning preferred Skills & Competencies Strong technical writing skills with ability to author clear, compliant documentationSolid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)Understanding of GDP requirements and ALCOA+ data integrity principlesExcellent communication and interpersonal skills with ability to interface across all organizational levelsStrong project management and organizational skillsAbility to work independently with minimal supervision while also functioning effectively in a team environmentSelf-motivated with demonstrated initiative and problem-solving abilitiesProficiency in Microsoft Office Suite; experience with electronic validation systems a plus Working Conditions On-site presence required; may involve work in manufacturing, laboratory, and utility areasAbility to gown into cleanroom environments as requiredOccasional flexibility in schedule and travel may be needed to support project timelines or production schedules er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.