Senior Validation Engineer

Senior Validation Engineer – 503A Sterile Compounding

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 <797> , USP <795> , USP <800> , USP <1079> , 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.

Essential Duties & Responsibilities

Validation & Qualification

• Lead qualification and validation activities for sterile compounding operations, including:
• Equipment qualification-IQ/OQ/PQ
• Facility qualification
• Utility qualification
• Process validation
• Shipping validation
• Cleaning validation
• Develop and execute validation protocols for:
• Temperature mapping studies
• Refrigerators/freezers/Incubators/Controlled rooms
• Autoclaves
• Depyrogenation ovens
• Cleanrooms
• ISO 5 PECs
• Environmental monitoring systems
• Support cleanroom certification activities including:
• Smoke studies
• HEPA integrity testing
• Differential pressure evaluation
• 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 <1079> .
• 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
• Contamination control
• 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
• Risk assessments
• Change controls
• Ensure validation documentation is inspection-ready and compliant with:
• USP <797>
• USP <1079>
• USP <659>
• ISO 14644
• FDA process validation guidance
• applicable GDP/GMP principles
• 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
• HVAC upgrades
• 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 <797> , USP <1079> , 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
• Strong risk-based decision-making capabilities
• Comfortable interacting with auditors, inspectors, and executive leadership