Process Engineer – Solid Dose

Hims & Hers

10d

About The Position

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.

Requirements

• 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 <795>, USP <800>, 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.

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., <795>, <800>, 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.

Benefits

• 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)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees