Aseptic Compounding Process Engineer

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.About the Role: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.Work EnvironmentWork performed in ISO-classified cleanrooms and controlled environments, requiring gowning and aseptic behaviorsOffice-based engineering, documentation, and analysis workOccasional off-hours or on-call support for manufacturing operations and critical activitiesYou Will:Aseptic Process & Equipment EngineeringDesign, 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 ComplianceEnsure 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 & TroubleshootingInvestigate 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 CollaborationPartner 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 ManagementMaintain 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, i ... (truncated, view full listing at source)