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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking an Industrial Engineering Manager to lead onsite Operations and Industrial Engineering teams at their Arizona compounding pharmacy facility. This role oversees teams supporting Dispense and Fulfillment, Non-Sterile Compounding, and Sterile Compounding areas, ensuring system reliability, operational excellence, data integrity, and regulatory compliance.
You will lead a small, agile group of 2-3 direct reports while providing hands-on technical expertise. Key responsibilities include:
**Team Leadership & Operations:**
- Lead day-to-day operations of the Industrial Engineering Team, providing onsite presence and guidance for mid to junior level staff
- Serve as main point of contact for cross-functional groups and coordinate emergency response
- Develop and maintain engineering policies and procedures aligned with site and company standards
- Own critical engineering support systems including EMS/BMS, HVAC control, Engineering Change Management, and CAPEX/OPEX budgets
**Technical Expertise:**
- Serve as local subject matter expert for Dispense and Fulfillment, Non-Sterile Compounding, or Sterile Compounding
- Coordinate onsite support by identifying improvement projects and executing approved plans
- Apply regulatory knowledge to manage risk and avoid product quality roadblocks
- Support installation, commissioning, and qualification of assigned systems and equipment
- Troubleshoot equipment and facilities issues
**Compliance & Cross-Functional Support:**
- Ensure systems meet regulatory documentation standards (21 CFR, EU Annex 1, USP 797)
- Consult with validation teams on IQ/OQ protocols, URS, FRS, and SOPs for automation systems
- Support internal and regulatory audits
- Interface with maintenance, validation, QA, and facilities engineering teams
- Work with vendors and contractors on system implementation, upgrades, and ongoing support
The role reports to the network-level Industrial Engineering Manager and requires willingness to travel for vendor FATs and punch list activities.
**Requirements:**
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or related technical field
- 5-7 years of experience in Engineering or similar support roles in regulated environments (pharmaceutical, biotech, medical device, or cleanroom facilities)
- Working knowledge of sterile filling, tableting, liquid filling, powder blending, package handling, facility operation, and facility design
- Understanding of regulatory compliance requirements (21 CFR, EU Annex 1, USP 797)
- Strong analytical, problem-solving, and communication skills with ability to work independently and across cross-functional teams
- Proficiency in process mapping, data analysis, root cause analysis, and statistical tools for performance improvement
- Experience with AutoCAD or similar facility layout and engineering design tools
- Excellent cross-functional leadership and stakeholder management skills
- Hands-on experience supporting 503A and/or 503B compounding operations with working knowledge of pharmacy regulatory standards
- Excellent written and verbal communication skills
**Working Conditions:**
- Position requires working with Hazardous Drugs (HD) and wearing appropriate PPE (gloves, respiratory protection, gown)
- Medical approval required to wear respiratory protection (N95, full face respirator, SCBA, or PAPR)
- Physical exertion required: walking up to 50%, standing up to 100%, squatting/bending up to 20%, lifting up to 80% of time for up to 12-hour shifts; must lift up to 50 lbs
- Must confirm understanding of potential reproductive risks (teratogenicity, carcinogenicity, reproductive effects) from handling hazardous drugs
