{"schemaVersion":"jobsearcher.job.v1","id":"da03e72fa3725abd48904b14","url":"https://jobsearcher.com/jobs/da03e72fa3725abd48904b14","canonicalUrl":"https://jobsearcher.com/jobs/da03e72fa3725abd48904b14","title":"Process Engineer – Sterile Compounding","description":"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.\nHims & 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.\nAbout the Role:\nWe 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.\nYou Will:\nProcess Design & Optimization\nDesign and optimize sterile injectable compounding processes for HD and NHD products, focusing on aseptic technique, fluid path design, and containment.\nSelect and integrate equipment including laminar flow hoods, oRABS, peristaltic pumps, and filtration units with consideration for single-use vs. reusable components.\nPerform risk assessments (e.g., FMEA), identify CPPs and CQAs, and apply Lean and Six Sigma methodologies.\nConduct time studies, process mapping, and capacity analysis to streamline batch production and reduce waste.\nApply principles of lean manufacturing and continuous improvement (Kaizen, Six Sigma) to compounding and fill/finish workflows.\nSterile Compounding & Aseptic Practices\nSupport aseptic technique development and batch execution for terminally sterilized and aseptically filled products.\nCollaborate with cleanroom personnel on proper gowning, material/personnel flow, and HEPA-filtered environment controls.\nWork with QA to ensure compliance with USP , , NIOSH, and cGMP requirements for hazardous drug handling and containment.\nEquipment & Facility Support\nSpecify and support installation and qualification of compounding equipment such as biosafety cabinets (BSCs), laminar airflow workstations (LAFW), autoclaves, filtration units, and isolators.\nPartner with validation teams on IQ/OQ/PQ for sterile compounding equipment and critical systems.\nAssist in airflow visualization studies, pressure differential control, and HVAC balancing for sterile suites.\nProcess Validation & Equipment Qualification\nDevelop process validation protocols (PV) for new and existing products and participate in execution and data analysis.\nAuthor and maintain SOPs, batch records, deviation reports, and process change documentation in compliance with internal procedures and regulatory expectations.\nSupport cleaning validation, media fill simulations, and environmental monitoring investigations when deviations occur.\nParticipate in IQOQ execution activities onsite for protocol execution and work with QA teams to ensure requirements are checked per compliance and signoff is obtained.\nRegulatory Compliance & Documentation\nEnsure all activities comply with USP , , FDA cGMP, and ISO standards (e.g., ISO 14644).\nPrepare and maintain SOPs, risk assessments, deviation reports, CAPAs, and change control documentation.\nTechnology Transfer & Collaboration\nLead technology transfer efforts for new injectable products into manufacturing.\nCollaborate with QA, validation, pharmacy, engineering, and manufacturing teams to ensure successful implementation and operational readiness.\nTroubleshooting & Continuous Improvement\nAnalyze process data to monitor trends and drive continuous improvement in compounding performance and efficiency.\nTroubleshoot equipment malfunctions, process deviations, and facility issues impacting sterile production.\nAudit Readiness\nEnsure documentation and systems are audit-ready for internal audits and external inspections by FDA or State Boards.\nParticipate in regulatory inspections and provide technical support regarding process design and validation.\nYou Have:\nBachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.\n5+ years of hands-on experience in sterile injectable pharmaceutical manufacturing, including 503A or 503B operations.\nIn-depth knowledge of aseptic processing, cleanroom practices, hazardous drug handling, and fill/finish production.\nExperience with laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and single-use vs. reusable component systems.\nStrong understanding of USP , , cGMP, FDA 21 CFR Part 210/211, and ISO 14644 standards.\nProficiency in AutoCAD, Microsoft Office Suite, and documentation systems such as Veeva or MasterControl.\nStrong analytical and problem-solving skills, with the ability to troubleshoot complex technical issues.\nExcellent written and verbal communication skills and the ability to work effectively across cross-functional teams.\nHands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of USP , , , cGMP, and pharmacy regulatory standards.\nDemonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems.\nAdvanced knowledge of Lean, Six Sigma, and Kaizen methodologies, with a track record of executing large-scale process improvements and continuous improvement initiatives.\nExpertise in sterile and/or non-sterile pharmacy workflows, compounding suite design, hazardous drug handling, and regulatory readiness.\nStrong 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.\nExcellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.\nWillingness to travel as required for vendor FATs and document punch list items for correction.\nOur Benefits (there are more but here are some highlights):\nCompetitive salary & equity compensation for full-time roles\nUnlimited PTO, company holidays, and quarterly mental health days\nComprehensive health benefits including medical, dental & vision, and parental leave\nEmployee Stock Purchase Program (ESPP)\n401k benefits with employer matching contribution\nOffsite team retreats\nWe 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.\nHims 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.\nIt 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.\nHims & 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. Please do not send resumes to this email address.\nTo learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.","company":"Hims Hers","rawCompany":"hims hers","city":"Gilbert","state":"AZ","isRemote":false,"isActive":false,"createdAt":"2026-04-09T13:28:49.797Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer – Sterile Compounding","description":"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.\nHims & 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.\nAbout the Role:\nWe 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.\nYou Will:\nProcess Design & Optimization\nDesign and optimize sterile injectable compounding processes for HD and NHD products, focusing on aseptic technique, fluid path design, and containment.\nSelect and integrate equipment including laminar flow hoods, oRABS, peristaltic pumps, and filtration units with consideration for single-use vs. reusable components.\nPerform risk assessments (e.g., FMEA), identify CPPs and CQAs, and apply Lean and Six Sigma methodologies.\nConduct time studies, process mapping, and capacity analysis to streamline batch production and reduce waste.\nApply principles of lean manufacturing and continuous improvement (Kaizen, Six Sigma) to compounding and fill/finish workflows.\nSterile Compounding & Aseptic Practices\nSupport aseptic technique development and batch execution for terminally sterilized and aseptically filled products.\nCollaborate with cleanroom personnel on proper gowning, material/personnel flow, and HEPA-filtered environment controls.\nWork with QA to ensure compliance with USP , , NIOSH, and cGMP requirements for hazardous drug handling and containment.\nEquipment & Facility Support\nSpecify and support installation and qualification of compounding equipment such as biosafety cabinets (BSCs), laminar airflow workstations (LAFW), autoclaves, filtration units, and isolators.\nPartner with validation teams on IQ/OQ/PQ for sterile compounding equipment and critical systems.\nAssist in airflow visualization studies, pressure differential control, and HVAC balancing for sterile suites.\nProcess Validation & Equipment Qualification\nDevelop process validation protocols (PV) for new and existing products and participate in execution and data analysis.\nAuthor and maintain SOPs, batch records, deviation reports, and process change documentation in compliance with internal procedures and regulatory expectations.\nSupport cleaning validation, media fill simulations, and environmental monitoring investigations when deviations occur.\nParticipate in IQOQ execution activities onsite for protocol execution and work with QA teams to ensure requirements are checked per compliance and signoff is obtained.\nRegulatory Compliance & Documentation\nEnsure all activities comply with USP , , FDA cGMP, and ISO standards (e.g., ISO 14644).\nPrepare and maintain SOPs, risk assessments, deviation reports, CAPAs, and change control documentation.\nTechnology Transfer & Collaboration\nLead technology transfer efforts for new injectable products into manufacturing.\nCollaborate with QA, validation, pharmacy, engineering, and manufacturing teams to ensure successful implementation and operational readiness.\nTroubleshooting & Continuous Improvement\nAnalyze process data to monitor trends and drive continuous improvement in compounding performance and efficiency.\nTroubleshoot equipment malfunctions, process deviations, and facility issues impacting sterile production.\nAudit Readiness\nEnsure documentation and systems are audit-ready for internal audits and external inspections by FDA or State Boards.\nParticipate in regulatory inspections and provide technical support regarding process design and validation.\nYou Have:\nBachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.\n5+ years of hands-on experience in sterile injectable pharmaceutical manufacturing, including 503A or 503B operations.\nIn-depth knowledge of aseptic processing, cleanroom practices, hazardous drug handling, and fill/finish production.\nExperience with laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and single-use vs. reusable component systems.\nStrong understanding of USP , , cGMP, FDA 21 CFR Part 210/211, and ISO 14644 standards.\nProficiency in AutoCAD, Microsoft Office Suite, and documentation systems such as Veeva or MasterControl.\nStrong analytical and problem-solving skills, with the ability to troubleshoot complex technical issues.\nExcellent written and verbal communication skills and the ability to work effectively across cross-functional teams.\nHands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of USP , , , cGMP, and pharmacy regulatory standards.\nDemonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems.\nAdvanced knowledge of Lean, Six Sigma, and Kaizen methodologies, with a track record of executing large-scale process improvements and continuous improvement initiatives.\nExpertise in sterile and/or non-sterile pharmacy workflows, compounding suite design, hazardous drug handling, and regulatory readiness.\nStrong 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.\nExcellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.\nWillingness to travel as required for vendor FATs and document punch list items for correction.\nOur Benefits (there are more but here are some highlights):\nCompetitive salary & equity compensation for full-time roles\nUnlimited PTO, company holidays, and quarterly mental health days\nComprehensive health benefits including medical, dental & vision, and parental leave\nEmployee Stock Purchase Program (ESPP)\n401k benefits with employer matching contribution\nOffsite team retreats\nWe 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.\nHims 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.\nIt 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.\nHims & 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. Please do not send resumes to this email address.\nTo learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.","datePosted":"2026-04-09T13:28:49.797Z","dateModified":"2026-04-09T13:28:49.797Z","hiringOrganization":{"@type":"Organization","name":"Hims Hers","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gilbert","addressRegion":"AZ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"da03e72fa3725abd48904b14"},"url":"https://jobsearcher.com/jobs/da03e72fa3725abd48904b14"}}