Sterile Technical Services (TS) Engineer

Sterile Technical Services (Ts) Engineer

The Sterile Technical Services (TS) Engineer is responsible for the design, qualification, validation, optimization, and lifecycle support of aseptic compounding processes, facilities, and equipment used in the production of sterile drug products. This role ensures sustained compliance with USP <797> , applicable FDA and cGMP requirements, and internal quality standards, while driving continuous improvement in sterility assurance, process robustness, and operational efficiency.

The position works cross-functionally with Operations, Quality, Validation, Microbiology, and Maintenance teams to support routine manufacturing, new product introductions, technology transfers, and regulatory inspections.

Work performed in ISO-classified cleanrooms and controlled environments, requiring gowning and aseptic behaviors. Office-based engineering, documentation, and analysis work. Occasional off-hours or on-call support for manufacturing operations and critical activities.

You Will:

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.

You Have:

• 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.

Our Benefits (There Are More But Here Are Some Highlights):

• 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