Senior Validation Engineer

The Senior Validation Engineer is responsible for leading validation, qualification, requalification, environmental monitoring, shipping studies, and sterility assurance activities supporting both sterile and non-sterile compounding pharmacy operations. This role supports compliance with USP , USP , USP , USP , applicable FDA guidance, and industry best practices across sterile, non-sterile, and hazardous drug (HD) compounding operations. The position works cross-functionally with Quality Assurance, Pharmacy Operations, Engineering, Facilities, and external vendors to support sterile manufacturing operations, regulatory readiness, and continuous quality improvement initiatives. This role is highly hands-on and requires strong technical writing, investigation, risk assessment, and project management skills within regulated compounding environments. Validation & Qualification Lead qualification and validation activities for sterile compounding operations, including: Facility qualification Utility qualification Process validation Develop and execute validation protocols for: Autoclaves Depyrogenation ovens Cleanrooms ISO 5 PECs Support cleanroom certification activities including: Smoke studies HEPA integrity testing Recovery testing Perform risk assessments and scientific justification for deviations, excursions, and validation outcomes. Shipping & Stability Support Lead shipping qualification studies for refrigerated and controlled-temperature products in accordance with USP . Perform: Mean Kinetic Temperature (MKT) analysis Temperature mapping Shipping lane risk assessment Thermal excursion investigations Packaging configuration evaluations Coordinate external laboratory testing for potency, endotoxin, sterility, or physical distribution simulation studies as required. Environmental Monitoring & Sterility Assurance Support environmental monitoring program design and continuous improvement initiatives. Assist with implementation and management of continuous monitoring systems Support investigations related to: EM excursions Sterility assurance Facility performance Support media fill and aseptic process simulation activities. Equipment Calibration & Asset Management Support and oversee equipment calibration programs for critical compounding, laboratory, facility, and monitoring equipment across sterile, non-sterile, and hazardous drug operations. Coordinate calibration scheduling, vendor management, documentation review, and asset tracking activities. Review and maintain calibration records, certificates, tolerances, and traceability documentation to ensure inspection readiness and regulatory compliance. Support implementation and maintenance of centralized equipment tracking systems and asset management programs. Assist with out-of-tolerance investigations, impact assessments, corrective actions, and equipment lifecycle management activities. Ensure calibration activities are performed in accordance with applicable SOPs, manufacturer recommendations, and regulatory expectations. Documentation & Compliance Author and review: SOPs Validation protocols Final summary reports Technical assessments CAPAs Deviations Change controls Ensure validation documentation is inspection-ready and compliant with: USP USP USP ISO 14644 FDA process validation guidance Support regulatory inspections, client audits, and internal audits. Project & Cross-Functional Support Coordinate validation-related shutdown activities and project timelines. Work closely with Engineering, Facilities, Pharmacy Operations, and QA during: equipment installations facility modifications operational expansions Interface with certification vendors, laboratories, and external contractors. Support implementation of continuous improvement initiatives across sterile operations. Qualifications Bachelor’s degree in Engineering, Microbiology, Pharmaceutical Sciences, Biological Sciences, or related technical discipline required. Minimum 7 years of validation experience in, sterile compounding, pharmaceutical manufacturing biotechnology, medical device and healthcare regulated environments Minimum 3 years supporting aseptic or sterile operations preferred. Experience in 503A or 503B environments strongly preferred Excellent technical writing and documentation skills Strong analytical and problem-solving abilities Ability to manage multiple projects simultaneously Strong communication and cross-functional collaboration skills Ability to work independently in fast-paced regulated environments Strong attention to detail and regulatory mindset Technical Knowledge Strong working knowledge of : USP , USP , ISO 14644, Environmental monitoring programs, Sterility assurance principles, Shipping validation, MKT calculations, Temperature mapping, Cleanroom certification, Smoke studies, HVAC systems and differential pressure control, Autoclave and depyrogenation validation, GDP/GMP documentation practices, EMS/BMS, QMS and Cleaning Validation Travel Requirements Ability and willingness to travel up to 25% as needed to support multi-site operations, facility qualifications, certifications, audits, shutdown activities, vendor coordination, and validation execution activities Preferred Attributes Experience supporting rapid operational growth and startup environments Experience managing shutdowns, facility upgrades, or cleanroom expansions Ability to balance scientific rigor with operational practicality Comfortable interacting with auditors, inspectors, and executive leadership #J-18808-Ljbffr