Validation Engineer

Validation Engineer Book here for more information/consideration: (Use the "Apply for this Job" box below). The Validation Engineer ensures that all critical equipment, utilities, and facility systems in a regulated aseptic pharmaceutical environment are fully qualified, validated, and maintained in a consistent state of control. This role supports sterile manufacturing operations by planning and executing validation activities, maintaining robust documentation, and ensuring ongoing inspection readiness. The Validation Engineer works closely with Quality Assurance, Operations, Facilities, and Engineering teams to uphold sterility assurance, compliance with current Good Manufacturing Practices (cGMP), and alignment with FDA 503B guidance and Annex 1 expectations.

Responsibilities + Plan, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment, including isolators, cleanroom HVAC systems, bio-safety cabinets, laminar flow hoods, pooling and filling equipment, and environmental monitoring systems. + Validate and maintain the qualified state of facility utilities such as compressed air, clean steam, water for injection (WFI), HVAC, and differential pressure systems to support aseptic manufacturing.

+ Support cleanroom qualification activities, including ISO classification, airflow visualization studies, and recovery testing, to ensure controlled environmental conditions. + Write, execute, and review validation protocols, reports, and change controls, including those provided by third parties, in accordance with FDA 503B guidance, cGMP, and Annex 1 requirements. + Maintain validation master plans (VMP), equipment qualification files, and complete lifecycle documentation to demonstrate ongoing control of systems and equipment.

+ Ensure all validation activities meet data integrity expectations, including adherence to ALCOA+ principles for accurate, complete, and reliable records. + Provide validation and qualification support to Quality and Operations teams to ensure equipment and facility conditions consistently support aseptic processing. + Support aseptic processing studies such as media fills, smoke studies, and contamination control strategy implementation to maintain sterility assurance.

+ Participate in investigations related to equipment failures, environmental excursions, or sterility assurance risks, and contribute to root cause analysis and corrective actions. + Oversee calibration and preventive maintenance schedules for critical equipment to ensure reliable performance and regulatory compliance. + Ensure vendors and service providers follow GMP standards and provide complete, compliant calibration certificates, preventive maintenance records, and service reports.

+ Review and approve calibration certificates, preventive maintenance records, and service reports to verify accuracy and completeness. + Evaluate equipment and facility changes for potential validation impact and define appropriate qualification or requalification activities. + Perform risk assessments, including Failure Modes and Effects Analysis (FMEA) and hazard analyses, to support change control decisions and prioritize mitigation actions. + Ensure requalification activities are completed following equipment modifications, repairs, or deviations to maintain validated status.

+ Maintain validation documentation in an audit-ready state to support internal audits and regulatory inspections. + Support internal audits and FDA inspections by presenting validation evidence, explaining validation strategies, and responding to technical questions. + Identify gaps in validation and compliance systems and drive continuous improvement initiatives to enhance robustness, efficiency, and regulatory alignment. + Collaborate cross-functionally with Quality Assurance, Operations, Facilities, and Engineering to align validation activities with production needs and regulatory expectations.

Essential Skills + Proven experience planning, executing, and documenting IQ/OQ/PQ for equipment such as isolators, cleanroom HVAC, bio-safety cabinets, laminar flow hoods, and sterile filling equipment. + Hands-on experience with equipment qualification, cleanroom validation, and aseptic processing support in a regulated pharmaceutical environment. + Experience overseeing equipment calibration programs and preventive maintenance schedules for critical systems. + Strong understanding of cGMP requirements and practical experience applying them in aseptic pharmaceutical manufacturing.

+ Demonstrated familiarity with FDA 503B guidance and Annex 1 expectations for sterile manufacturing. + Experience supporting or conducting media fills, smoke studies, and contamination control strategy activities. +

Experience with risk assessment methodologies such as FMEA and hazard analysis in support of change control. + Investigator training and experience writing clear, structured investigation reports. +…