Aseptic Compounding Process Engineer

Hims & Hers • New Albany, OH

3d

About The Position

The Aseptic Compounding Process 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.

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 Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level