СШАIndustrial Engineering Manager
2 нед. назад
СШАLeadOnsite
operations managementprocess improvementregulatory compliance
Lead onsite operations and industrial engineering teams supporting pharmacy compounding and fulfillment to ensure system reliability and compliance.
Обязанности
- We are seeking an Industrial Engineering Lead to lead the onsite Operations and Industrial Engineering Teams supporting Dispense and Fulfillment, Non-Sterile Compounding, and Sterile Compounding areas in our Arizona facility. This individual will lead the day to day engineering operations as well as provide technical expertise for a growing compounding pharmacy. This role plays a critical part in ensuring system reliability, operational excellence, data integrity, and regulatory compliance across all facilities.
- The ideal candidate will lead a small, agile group of experts as well as provide their own technical expertise for processing areas.
- This role reports to the network level Industrial Engineering Manager as part of the larger Industrial Engineering organization.
- This role will be responsible for 2-3 direct reports.
Требования
- -Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related technical field.
- -5-7 years of experience working in Engineering or similar support group 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 such as 21 CFR, EU Annex 1, and USP 797.
- -Strong analytical, problem-solving, and communication skills with the ability to work independently, across cross-functional teams and the ability to troubleshoot complex technical issues. .
- -Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools.
- -Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
- -Willingness to travel as required for vendor FATs and document punch list items for correction.
- -Hands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of pharmacy regulatory standards.
- -Excellent written and verbal communication skills and the ability to work effectively across cross-functional teams.
Условия
- 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)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats
- Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're 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.
- To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement .
Другое
- 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, we’re 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 company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.
- Lead the day to day operations of the Industrial Engineering Team providing onsite presence and guidance for mid to junior level staff.
- Serve as the main point of contact for cross functional groups onsite. Respond to and coordinate emergency response delegating tasks where appropriate.
- Develop and maintain engineering policies and procedures in alignment with site and company standards ensuring compliance to all relevant regulatory requirements.
- Serve as the business owner for critical engineering support systems including EMS/BMS, HVAC control, Engineering Change Management, and CAPEX/OPEX budgets.
- Serve as a local SME for either Dispense and Fulfillment, Non-Sterile Compounding, or Sterile Compounding.
- Coordinate onsite support of functional areas by working closely with peer groups to identify improvement projects and then execute approved project plans in an efficient manner.
- Understand all regulatory requirements to effectively manage risk. Serve as a key advisor to site operations applying knowledge to effectively avoid potential product quality roadblocks.
- Support installation, commissioning, and qualification of all assigned systems and equipment.
- Troubleshoot equipment and facilities issues
- Ensure systems meet relevant regulatory documentation standards.
- Consult with validation to prepare and maintain validation documentation (e.g., IQ/OQ protocols), URS, FRS, and SOPs related to automation systems.
- Support internal and regulatory audits.
- Interface with maintenance, validation, QA, and facilities engineering teams to support ongoing compounding and fulfillment operations.
- Work with vendors and contractors during new system implementation or upgrades as well as ongoing system support.