Process Engineer - Sterile Compounding

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. 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 sign‑off 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 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: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline. 5+ years of hands‑on experience in sterile injectable pharmaceutical manufacturing, including 503A or 503B operations. In‑depth knowledge of aseptic processing, cleanroom practices, hazardous drug handling, and fill/finish production. Experience with laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and single‑use vs. reusable component systems. Strong understanding of USP , , cGMP, FDA 21 CFR Part 210/211, and ISO 14644 standards. Proficiency in AutoCAD, Microsoft Office Suite, and documentation systems such as Veeva or MasterControl. Strong analytical and problem‑solving skills, with the ability to troubleshoot complex technical issues. Excellent written and verbal communication skills and the ability to work effectively across cross‑functional teams. Hands‑on experience supporting 503A and/or 503B compounding operations, with working knowledge of USP , , , cGMP, and pharmacy regulatory standards. Demonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems. Advanced knowledge of Lean, Six Sigma, and Kaizen methodologies, with a track record of executing large‑scale process improvements and continuous improvement initiatives. Expertise in sterile and/or non‑sterile pharmacy workflows, compounding suite design, hazardous drug handling, and regulatory readiness. Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools. Excellent cross‑functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams. Willingness to travel as required for vendor FATs and document punch‑list items for correction. Our Benefits (there are more but here are some highlights): Competitive salary & equity compensation for full‑time roles Unlimited PTO, company holidays, and quarterly mental health days Comprehensive health benefits including medical, dental & vision, and parental leave Employee Stock Purchase Program (ESPP) 401(k) benefits with employer matching contribution Offsite team retreats 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 View email address on click.appcast.io 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. Please do not send resumes to this email address. #J-18808-Ljbffr Dormont Manufacturing Co