Process Engineer – Solid Dose
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Job Location:
Gilbert, AZ - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit 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. 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 posttechnology 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. Bachelors degree in Chemical Engineering Mechanical Engineering Industrial Engineering Pharmaceutical Engineering or a related technical discipline. 35 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. 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: ICYou Will:
Process Ownership & Solid Dose Manufacturing
Process Engineering Optimization & Control
Equipment Specification & Engineering Documentation
Equipment Lifecycle Calibration & Qualification Support
Quality Compliance & Regulatory Readiness
Technology Transfer & Cross-Functional Collaboration
Troubleshooting & Continuous Improvement
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
