Process Engineer – Sterile Compounding

Process Engineer – Sterile Compounding 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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: We are seeking a skilled and detail-oriented Process Engineer to support sterile injectable compounding operations within our 503A and 503B facilities. This role requires hands-on experience in sterile injectable manufacturing, including both hazardous (HD) and non-hazardous (NHD) drug products. The ideal candidate will be responsible for designing, optimizing, and validating aseptic processes, with a deep understanding of laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and the selection and management of single-use versus reusable components. YOU WILL: PROCESS DESIGN & OPTIMIZATION - Design and optimize sterile injectable compounding processes for HD and NHD products, focusing on aseptic technique, fluid path design, and containment. - Select and integrate equipment including laminar flow hoods, oRABS, peristaltic pumps, and filtration units with consideration for single-use vs. reusable components. - Perform risk assessments (e.g., FMEA), identify CPPs and CQAs, and apply Lean and Six Sigma methodologies. - Conduct time studies, process mapping, and capacity analysis to streamline batch production and reduce waste. - Apply principles of lean manufacturing and continuous improvement (Kaizen, Six Sigma) to compounding and fill/finish workflows. STERILE COMPOUNDING & ASEPTIC PRACTICES - Support aseptic technique development and batch execution for terminally sterilized and aseptically filled products. - Collaborate with cleanroom personnel on proper gowning, material/personnel flow, and HEPA-filtered environment controls. - Work with QA to ensure compliance with USP , , NIOSH, and cGMP requirements for hazardous drug handling and containment. EQUIPMENT & FACILITY SUPPORT - Specify and support installation and qualification of compounding equipment such as biosafety cabinets (BSCs), laminar airflow workstations (LAFW), autoclaves, filtration units, and isolators. - Partner with validation teams on IQ/OQ/PQ for sterile compounding equipment and critical systems. - Assist in airflow visualization studies, pressure differential control, and HVAC balancing for sterile suites. PROCESS VALIDATION & EQUIPMENT QUALIFICATION - Develop process validation protocols (PV) for new and existing products and participate in execution and data analysis. - Author and maintain SOPs, batch records, deviation reports, and process change documentation in compliance with internal procedures and regulatory expectations. - Support cleaning validation, media fill simulations, and environmental monitoring investigations when deviations occur. - Participate in IQOQ execution activities onsite for protocol execution and work with QA teams to ensure requirements are checked per compliance and signoff is obtained. REGULATORY COMPLIANCE & DOCUMENTATION - Ensure all activities comply with USP , , FDA cGMP, and ISO standards (e.g., ISO 14644). - Prepare and maintain SOPs, risk assessment ... (truncated, view full listing at source)