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:
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 <797>, <800>, 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.
Regulatory Compliance & Documentation
Ensure all activities comply with USP <797>, <800>, FDA cGMP, and ISO standards (e.g., ISO 14644).
Prepare and maintain SOPs, risk assessments, deviation reports, CAPAs, and change control documentation.
Technology Transfer & Collaboration
Lead technology transfer efforts for new injectable products into manufacturing.
Collaborate with QA, validation, pharmacy, engineering, and manufacturing teams to ensure successful implementation and operational readiness.
Troubleshooting & Continuous Improvement
Analyze process data to monitor trends and drive continuous improvement in compounding performance and efficiency.
Troubleshoot equipment malfunctions, process deviations, and facility issues impacting sterile production.
Audit Readiness
Ensure documentation and systems are audit-ready for internal audits and external inspections by FDA or State Boards.
Participate in regulatory inspections and provide technical support regarding process design and validation.
You Have:
Our Benefits:
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
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