Hims & Hers is hiring a Process Engineer – Solid Dose

Hims & Hers is seeking a Process Engineer to support our non-sterile solid oral dose compounding operations within 503A and 503B facilities. You will be responsible for designing, optimizing, and validating robust manufacturing processes for tablet and capsule products, ensuring they meet quality and compliance standards. This role is central to our mission of making better health outcomes easier to achieve through reliable and efficient manufacturing.

What You'll Do

• Own the design, implementation, and lifecycle management of non-sterile solid oral dose manufacturing processes for tablet and capsule products.
• Define and control unit operations including weighing, dispensing, powder transfer, blending, sifting, compression, encapsulation, dedusting, and packaging.
• Serve as the process owner post-technology transfer, maintaining process intent and ensuring consistent execution.
• 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.
• Analyze process data (e.g., blend uniformity, weight variation, tablet hardness, capsule fill weight) to assess performance 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).
• Support equipment selection, vendor engagement, and technical evaluations.
• 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 supports effective cleaning.
• Assist with facility and room design considerations, including material and personnel flow, pressure differentials, and containment strategies.
• Ensure solid dose processes are designed and operated in compliance with applicable USP chapters 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 audits and inspections.
• Support R&D-to-Compounding technology transfer, ensuring formulation sensitivities and process risks are documented.
• Translate development and scale-up data into robust, repeatable manufacturing processes.
• Collaborate closely with Pharmacy, Manufacturing, Quality, Validation, Engineering, and EHS teams.
• 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.

What We're Looking For

• 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.

Technical Stack

• Microsoft Office Suite
• Veeva
• MasterControl

Team & Environment

You will collaborate closely with Pharmacy, Manufacturing, Quality, Validation, Engineering, and EHS teams to ensure seamless process execution and continuous improvement.

Benefits & Compensation

• Competitive salary & equity compensation
• 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

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.