Process Engineer – Solid Dose

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 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 ManufacturingOwn the design, implementation, and lifecycle 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 & ControlIdentify 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 R&D 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 DocumentationAuthor 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 SupportPartner 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 ReadinessEnsure solid dose processes are designed and o ... (truncated, view full listing at source)