hims
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,Cost tehokapital joint below and visit www.hims.com/careers-professionals.
About the Role We are seeking a skilled and detail-oriented Process Engineer to support non-sterile solid oral dose compounding operations within our 503A and 503B facilities. This role requires hands-on experience in tablet and capsule manufacturing, including both hazardous (HD) and non-hazardous (NHD) drug products. The ideal candidate will be responsible for designing, optimizing, and validating solid dose processes, with a strong understanding of powder handling, dispensing, material flow, blending, sifting, compression, encapsulation, and containment strategies.
You Will: Process Ownership & Solid Dose Manufacturing Own the design, implementation, and lifespan management of non-sterile solid oral dose manufacturing processes for tablet and capsule products, including both hazardous (HD) and non-hazardous (NHD) compounds.
Define and control unit operations including weighing, dispensing, powder transfer, blending, sifting, compression, encapsulation, dedusting and packaging with a focus on robustness, repeatability, quality, and operator safety.
Serve as the process owner post–technology transfer, maintaining process intent and ensuring consistent execution in routine compounding operations.
Process Engineering, Optimization & Control Identify and manage Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using risk-based tools such as FMEA.
Establish, optimize, and maintain equipment setpoints, operating ranges, and process control strategies following initial RéD tech transfer.
Analyze process data (e.g., blend uniformity, weight variation, tablet hardness, capsule fill weight) to assess performance, investigate deviations, and drive continuous improvement.
Apply Lean manufacturing and continuous improvement principles to improve throughput, reduce waste, and enhance process consistency.
Equipment Specification & Engineering Documentation Author and maintain User Requirement Specifications (URSs) for solid dose manufacturing and material handling equipment.
Develop, review, and interpret P&IDs, Functional Design Specifications (FDS), and Sequences of Operation (SOO) to clearly communicate process and equipment requirements.
Support equipment selection, vendor engagement, and technical evaluations, ensuring alignment with process intent, containment needs, cleanability, and compliance expectations.
Participate in FATs, SATs, commissioning, and startup activities for new or modified equipment.
Equipment Lifecycle, Calibration & Qualification Support Extendedمرارأمدزا], boys, Partner with Quality and Validation teams to support IQ/OQ/PQ for solid dose equipment and supporting systems.
Define process-relevant calibration requirements and ensure equipment remains fit for intended use.
Support cleaning validation activities and ensure equipment design and operating practices support effective and repeatable cleaning.
Assist with facility and room design considerations, including material and personnel flow, pressure differentials, and containment strategies for HD and NHD operations.
Quality, Compliance & Regulatory Readiness Ensure solid dose processes are designed and operated in compliance with applicable USP chapters (e.g., ,)
, and other relevant non-sterile guidance) and cGMP principles.
Author and maintain process-related SOPs, batch record content, risk assessments, and change control documentation.
Support deviation investigations, CAPAs, and data integrity practices related to solid dose manufacturing.
Maintain systems and documentation in an audit-ready state and provide technical support during internal audits and regulatory inspections.
Technology Transfer & Cross-Functional Collaboration Support R&D-to-Compounding technology transfer, ensuring formulation sensitivities, process risks, and control strategies are clearly documented and understood.
Actically translate development and scale-up data into robust, repeatable manufacturing processes suitable for routine compounding. Collaborate closely with Pharmacy, Manufacturing, Quality, Validation, Engineering, and EHS teams to ensure successful implementation and ongoing operation of solid dose processes.
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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,Cost tehokapital joint below and visit www.hims.com/careers-professionals.
About the Role We are seeking a skilled and detail-oriented Process Engineer to support non-sterile solid oral dose compounding operations within our 503A and 503B facilities. This role requires hands-on experience in tablet and capsule manufacturing, including both hazardous (HD) and non-hazardous (NHD) drug products. The ideal candidate will be responsible for designing, optimizing, and validating solid dose processes, with a strong understanding of powder handling, dispensing, material flow, blending, sifting, compression, encapsulation, and containment strategies.
You Will: Process Ownership & Solid Dose Manufacturing Own the design, implementation, and lifespan management of non-sterile solid oral dose manufacturing processes for tablet and capsule products, including both hazardous (HD) and non-hazardous (NHD) compounds.
Define and control unit operations including weighing, dispensing, powder transfer, blending, sifting, compression, encapsulation, dedusting and packaging with a focus on robustness, repeatability, quality, and operator safety.
Serve as the process owner post–technology transfer, maintaining process intent and ensuring consistent execution in routine compounding operations.
Process Engineering, Optimization & Control Identify and manage Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using risk-based tools such as FMEA.
Establish, optimize, and maintain equipment setpoints, operating ranges, and process control strategies following initial RéD tech transfer.
Analyze process data (e.g., blend uniformity, weight variation, tablet hardness, capsule fill weight) to assess performance, investigate deviations, and drive continuous improvement.
Apply Lean manufacturing and continuous improvement principles to improve throughput, reduce waste, and enhance process consistency.
Equipment Specification & Engineering Documentation Author and maintain User Requirement Specifications (URSs) for solid dose manufacturing and material handling equipment.
Develop, review, and interpret P&IDs, Functional Design Specifications (FDS), and Sequences of Operation (SOO) to clearly communicate process and equipment requirements.
Support equipment selection, vendor engagement, and technical evaluations, ensuring alignment with process intent, containment needs, cleanability, and compliance expectations.
Participate in FATs, SATs, commissioning, and startup activities for new or modified equipment.
Equipment Lifecycle, Calibration & Qualification Support Extendedمرارأمدزا], boys, Partner with Quality and Validation teams to support IQ/OQ/PQ for solid dose equipment and supporting systems.
Define process-relevant calibration requirements and ensure equipment remains fit for intended use.
Support cleaning validation activities and ensure equipment design and operating practices support effective and repeatable cleaning.
Assist with facility and room design considerations, including material and personnel flow, pressure differentials, and containment strategies for HD and NHD operations.
Quality, Compliance & Regulatory Readiness Ensure solid dose processes are designed and operated in compliance with applicable USP chapters (e.g., ,)
, and other relevant non-sterile guidance) and cGMP principles.
Author and maintain process-related SOPs, batch record content, risk assessments, and change control documentation.
Support deviation investigations, CAPAs, and data integrity practices related to solid dose manufacturing.
Maintain systems and documentation in an audit-ready state and provide technical support during internal audits and regulatory inspections.
Technology Transfer & Cross-Functional Collaboration Support R&D-to-Compounding technology transfer, ensuring formulation sensitivities, process risks, and control strategies are clearly documented and understood.
Actically translate development and scale-up data into robust, repeatable manufacturing processes suitable for routine compounding. Collaborate closely with Pharmacy, Manufacturing, Quality, Validation, Engineering, and EHS teams to ensure successful implementation and ongoing operation of solid dose processes.
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