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hims & hers · 13 hours ago

Process Engineer – Solid Dose

United States

Full-time

Remote

Mid, Senior Level

$100K/yr - $115K/yr

3+ years exp

Hims & Hers is a leading health and wellness platform focused on providing accessible healthcare solutions. They are seeking a skilled Process Engineer to support non-sterile solid oral dose compounding operations, responsible for designing, optimizing, and validating solid dose processes in compliance with regulatory standards.

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Responsibilities

Own 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

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 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

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

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

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

Support R&D-to-Compounding technology transfer, ensuring formulation sensitivities, process risks, and control strategies are clearly documented and understood

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

Provide hands-on technical support to troubleshoot process deviations, equipment issues, yield losses, and material flow challenges

Lead and participate in structured problem-solving efforts to improve safety, quality, efficiency, and compliance

Drive continuous improvement initiatives that strengthen process capability and operational reliability over time

Qualification

Solid oral dose manufacturingProcess validationPowder handlingCGMP complianceLean manufacturingAnalytical skillsTechnical documentationMicrosoft Office SuiteCommunication skillsProblem-solving skillsCross-functional collaboration

Required

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Pharmaceutical Engineering, or a related technical discipline

3–5+ years of hands-on experience in solid oral dose pharmaceutical manufacturing or compounding, including 503A and/or 503B operations

Strong knowledge of powder handling, blending, tableting, and capsuling processes

Experience working with hazardous drugs and associated containment and exposure control strategies

Solid understanding of USP , USP , FDA cGMP, and pharmacy regulatory standards

Experience supporting process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ)

Proficiency in 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

Willingness to travel as required for vendor activities and facility support