Process Engineer – Sterile Compounding- Mesa,AZ

hims & hers
United States
Workplace: OnsiteFull timeFunction: Industrial, Process & Manufacturing EngineeringExperience: 5+ yearsEducation: bachelorsSkills: ["Communication","Problem-solving","Leadership","Teamwork","Documentation"]

Detail-oriented Process Engineer to design, optimize, and validate aseptic sterile injectable compounding processes in HD/NHD facilities (503A/503B), ensuring regulatory compliance, equipment integration, and continuous improvement. You’ll work with laminar flow hoods, oRABS, and single-use vs reusable components, driving process design, validation, and technology transfer in a highly regulated pharma environment.

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FursaFursa
hims & hers
hims & hers
4 months ago

Process Engineer – Sterile Compounding- Mesa,AZ

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Source: Company careers pageValidated by: Fursa AI
Last checked: 21 hours agoStatus: Live

Job Summary

Detail-oriented Process Engineer to design, optimize, and validate aseptic sterile injectable compounding processes in HD/NHD facilities (503A/503B), ensuring regulatory compliance, equipment integration, and continuous improvement. You’ll work with laminar flow hoods, oRABS, and single-use vs reusable components, driving process design, validation, and technology transfer in a highly regulated pharma environment.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Industrial, Process & Manufacturing Engineering

Key Responsibilities

  • •Design and optimize sterile injectable compounding processes for HD and NHD products, focusing on aseptic technique, fluid path design, and containment.
  • •Select and integrate equipment including laminar flow hoods, oRABS, peristaltic pumps, and filtration units with consideration for single-use vs. reusable components.
  • •Perform risk assessments (e.g., FMEA), identify CPPs and CQAs, and apply Lean and Six Sigma methodologies.
  • •Conduct time studies, process mapping, and capacity analysis to streamline batch production and reduce waste.
  • •Apply principles of lean manufacturing and continuous improvement (Kaizen, Six Sigma) to compounding and fill/finish workflows.

Pay and Benefits

Perks:EquityPaid LeaveHealth InsuranceEspp401kRetreats

Key Requirements

  • •Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related technical discipline
  • •5+ years of hands-on experience in sterile injectable pharmaceutical manufacturing, including 503A or 503B operations
  • •In-depth knowledge of aseptic processing, cleanroom practices, hazardous drug handling, and fill/finish production
  • •Experience with laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and single-use vs. reusable component systems
  • •Strong understanding of USP <797>, <800>, cGMP, FDA 21 CFR Part 210/211, and ISO 14644 standards
Experience:5+ yearsSterile injectablePharmaceutical manufacturingCGMPCleanroomAseptic processing
Education:Bachelor's in Chemical Engineering
Skills:CommunicationProblem-solvingLeadershipTeamworkDocumentation
Tech Stack:AutoCADVeevaMasterControlExcelIQ/OQ/PQLAFWBSCs

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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