СШАPrincipal Facilities Engineer
3 нед. назад
СШАLeadOnsite
hvacelectricalcompressed airpurified waterbuilding automationcgmpequipment qualification
Experienced Principal Facilities Engineer to support critical facility and utility systems at a regulated pharmacy/manufacturing site adhering to cGMP standards.
Обязанности
- We are seeking an experienced Principal Facilities Engineer to support critical facility and utility systems at our New Albany, Ohio site, a regulated pharmacy/manufacturing facility operating under cGMP requirements. This role requires hands-on engineering expertise across HVAC, electrical, compressed air, purified water, and building automation systems, with a deep understanding of GMP compliance, equipment qualification, and facility reliability. The ideal candidate will serve as the on-site engineering authority during the Wednesday–Sunday shift, working hand-in-hand with the Maintenance team as the engineering point of contact whenever an issue arises.
Требования
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field; equivalent hands-on experience considered in lieu of a degree.
- 8-10 years of facilities engineering experience, including at least 7+ years in a GMP-regulated pharmaceutical, biotech, or manufacturing environment.
- Working knowledge of cGMP, FDA 21 CFR Part 210/211, and validation lifecycle documentation (IQ/OQ/PQ).
- Hands-on experience with critical building systems: HVAC (including cleanroom/controlled environments), electrical distribution, compressed air, purified water/WFI systems, environmental monitoring systems (EMS), and building automation (BMS) platforms.
- Ability to read and interpret engineering drawings, P&IDs, equipment specifications, and design documents.
- Experience coordinating with Maintenance teams on PM program execution and/or managing contractors.
- Strong troubleshooting skills and the ability to respond calmly and effectively to facility emergencies.
- CMMS familiarity (e.g., Maximo, UpKeep, MaintainX) preferred.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); familiarity with CAD tools (AutoCAD or equivalent) is a plus.
- PE licensure is not required.
- Must be able to work the scheduled shift — Wednesday–Sunday, 2:00 PM – 10:00 PM — with flexibility for on-call/emergency response outside scheduled hours (regular hours can adjust/shift when responding to on-call/emergency situations).
- Ability to lift up to 50 lbs, stand/walk for extended periods, work in mechanical rooms and at heights (ladders/lifts), and wear required PPE in varying temperatures, noise levels, and controlled/cleanroom environments.
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.
- Serve as the on-site engineering lead for facility systems (HVAC, electrical distribution, compressed air, purified/RO water, EMS, BMS/BAS, generators, fire/life safety) during the Wed–Sun shift.
- Review and redline design drawings, P&IDs, and specifications for new construction, renovation, and equipment installation projects to ensure code compliance, GMP suitability, and operational fit.
- Engage with HVAC design during construction, evaluating equipment specifications and system selection to confirm the right systems are chosen and correctly installed against the facility's URS and regulated environment requirements.
- Apply psychrometric analysis specific to the region's climate to validate HVAC system design, capacity, and performance.
- Develop and maintain utility system design standards and basis-of-design documentation for the site.
- Engage with vendors on existing equipment to optimize settings, evaluate upgrade opportunities, and improve system reliability.
- Provide on-site technical oversight during installation of facility and utility systems, serving as the point of contact between Hims & Hers and external vendors/contractors.
- Lead or support commissioning and qualification activities (IQ/OQ/PQ) for critical equipment and utility systems in the regulated environment.
- Manage acceptance testing, punch list closeout, and system turnover to operations for construction and capital projects.
- Ensure facility equipment and utility systems remain qualified and compliant with cGMP, FDA 21 CFR Part 210/211, and applicable state and local regulations.
- Ensure preventive maintenance contracts are in place for all facility equipment/utilities with appropriate SLAs and emergency dispatching protocols; Maintenance coordinates the resulting PMs and related CMMS work orders.
- Coach and support Maintenance Technicians on shift for system upkeep, preventive maintenance execution, and downtime/excursion remediation.
- Lead root cause investigations for equipment failures or excursions affecting GMP-relevant systems; partner with Quality on CAPAs and change controls.
- Manage change control processes for modifications to critical facility/utility systems, including impact assessments and requalification needs.
- Respond to critical alarms and emergency events (HVAC excursions, environmental excursions, power loss, water system failures) during shift hours and off-hours, escalating and documenting appropriately.
- Maintain accurate documentation: SOPs, work instructions, as-built records, validation records, and regulatory files.
- Ensure ongoing compliance with OSHA, EPA, NFPA, and local building/fire codes.
- Participate in EHS programs and support internal audits and regulatory inspections as a technical resource for facility and utility systems.
- Manage relationships with contractors and vendors for specialized maintenance, calibration, and capital project work.
- Support capital improvement and equipment installation projects — scoping, contractor coordination, and commissioning.
- Work cross-functionally with Operations, Maintenance, Quality, and Validation teams to align facility and utility performance with operational needs.