Responsibilities
- Aseptic Process & Equipment Engineering - Design, implement, and maintain aseptic compounding and sterile processing operations for sterile drug products.
- Support selection, installation, qualification, and lifecycle management of aseptic compounding equipment, including cleanroom systems and utilities.
- Lead or support IQ/OQ/PQ activities for equipment, facilities, and processes in regulated environments.
- Provide engineering support for ISO-classified cleanrooms, HVAC systems, and critical utilities impacting sterility assurance.
- Sterility Assurance & Regulatory Compliance - Ensure compliance with USP <797> (and USP <800>, where applicable), FDA regulations, and cGMP requirements.
- Author, review, and approve SOPs, validation protocols, risk assessments, and technical reports.
- Support and participate in media fills, environmental monitoring programs, gowning qualifications, and aseptic process simulations.
- Lead or support contamination investigations, deviation management, and CAPA development.
- Process Optimization & Troubleshooting - Investigate aseptic process deviations and equipment failures using structured root cause analysis.
- Apply risk management tools (e.g., FMEA) to identify and mitigate risks to sterility assurance.
- Drive continuous improvement initiatives to improve process robustness, yield, throughput, and compliance.
- Support remediation activities related to audits, inspections, or internal quality findings.
- Cross-Functional Collaboration - Partner closely with Compounding Operations, Quality Assurance, Validation, Microbiology, Facilities, and Maintenance.
- Provide technical support during regulatory inspections and audits, including FDA inspections and audit responses.
- Support technology transfer, scale-up, and new product introductions, including process readiness and validation planning.
- Documentation, Training & Knowledge Management - Maintain compliant, inspection-ready engineering and validation documentation.
- Train operations and technical staff on aseptic principles, equipment operation, contamination control, and best practices.
- Stay current with evolving regulatory guidance, industry standards, and emerging aseptic technologies.
Requirements
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Pharmacy, or a related technical field.
- 1-3+ years of experience in aseptic or sterile compounding, pharmaceutical manufacturing, or regulated cleanroom environments.
- Working knowledge of cGMP, USP <797> (and <800> where applicable), and aseptic processing principles.
- Hands-on experience with aseptic compounding, sterilization methods (e.g., steam, dry heat, filtration), and cleanroom operations.
- Experience supporting equipment qualification, process validation, and lifecycle management in regulated environments.
Nice to Have
- Master’s degree in Engineering or Pharmaceutical Sciences.
- Experience with isolators, RABS, single-use systems, or advanced aseptic automation.
- Lean, Six Sigma, or formal risk management training.
- Direct experience supporting FDA inspections, regulatory audits, or inspection remediation activities.
Benefits
- Competitive salary & equity compensation for full-time roles
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
