hims & hers · 1 day ago
Aseptic Compounding Process Engineer
New Albany, OH
Full-time
Onsite
Entry, Mid Level
1+ years expHims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. The Aseptic Compounding Process Engineer is responsible for the design, qualification, validation, optimization, and lifecycle support of aseptic compounding processes, ensuring compliance with relevant regulations while driving continuous improvement in sterility assurance and operational efficiency.
Health CareLifestyleMen'sWellnessWomen's
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
Qualification
Required
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
Preferred
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
Company
hims & hers
Hims is a wellness brand that helps men and women get access to products for skin care, hair loss, and sexual health.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Franklin TempletonIVPThrive Capital
2025-05-08Post Ipo Debt· $1B
2021-01-21Post Ipo Equity· $75M
2021-01-21IPO
Leadership Team
Andrew Dudum
Founder & CEO
Yemi Okupe
CFO
Recent News
The Motley Fool
2026-02-04
Company data provided by crunchbase