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
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Application Question(s):
- Do you require sponsorship to work in the United States? We can not provide any at this moment
Experience:
- Validation Engineer: 3 years (Required)
Work Location: In person
