Find & Apply For Facilities Manager Jobs in Apex, North Carolina

Facilities & Engineering Manager Reports to: CEO /

Head of Manufacturing Location:

Apex, NC - new 20,000 sq ft sterile injectable cGMP facility (on-site)

Type:

Full-time; direct hire; exempt; individual contributor

Compensation:

$115,000-$130,000 base, depending on experience. Performance Bonus. Benefits included. Job Summary The Facilities & Engineering Manager owns the building, utilities, process equipment, maintenance, calibration, pest control, and safety (EHS) at the Company's sterile injectable manufacturing site in Apex, NC. This is a hands-on, plant-floor role in a lean, build-stage environment, not an administrative one. In this startup environment, you will perform repairs, maintenance, and calibration yourself or ensure they are completed by qualified vendors and OEM service engineers. You will also manage outside contractors and support commissioning and qualification as the site moves toward commercialization. Mission Keep the Apex facility clean, secure, compliant, and running reliably, so that Manufacturing, Quality, and administrative teams can work without friction, and the site is always ready for a visitor, an inspection, or an audit. Why This Role

• Local, on-site role with no routine travel. A good fit for field service techs and traveling engineers who want to be home every night.
• Own the whole site: building, utilities, and equipment, with direct access to leadership.
• New facility and new equipment: learn each system from installation onward through SAT, commissioning, and qualification.
• 10% bonus, and room to grow in scope and title after commercial launch.
• Join the first team of associates creating the facility they want to work in and manage.

Lean team:

decisions happen fast and your work is visible.

• Veterans welcome: former Navy nuclear technicians (EMN, MMN, ETN) with GMP manufacturing experience are encouraged to apply. Traits & Behaviors Hands-on ownership, practical judgment, timely communication, follow-through with vendors, and an eye for quality work. Key Responsibilities Process Equipment & Utilities
• Hands-on maintenance and troubleshooting of the aseptic filling line, automated visual inspection, washer/autoclave, WFI/PW, clean steam, compressed air, process gases, labeler, freezers, coolers, cleanroom HVAC, Blue Mountain

RAM, EMS

(Rees Scientific), and other equipment as assigned. Maintenance & Calibration

• On-time preventive maintenance and calibration, performed directly or by OEM service engineers and calibration vendors, with no overdue work orders and prompt, accurate records in Blue Mountain RAM.
• Spare parts program management. Building Operations
• Hands-on HVAC, electrical, plumbing, door hardware, backup power, and general building repairs; decide when a licensed vendor is required. Handle routine building issues directly, especially during startup and commissioning.
• Ensure building finishes are kept to a consistent high standard.
• Own supply and scrub contracts and reorder systems for office, warehouse, cleaning, and changing room supplies; routine restocking may be shared with operations.
• Own the site pest control program. Security & Access
• Own building security: access control, alarms, keys, credentials, and contractor and visitor sign-in and escort. Vendor & Contract Management
• Manage contracts and vendors for cleaning, waste disposal, scrub laundry (including scheduled pickup and drop-off), pest control, landscaping, and fire/life safety.
• Schedule and coordinate calibration, HVAC certification, WFI, equipment OEM, electrical, and plumbing vendors.
• Evaluate vendor proposals on merit; know how service contracts are typically split or bundled in the local market.
• Oversee vendor work on site, accept it against specification, and manage vendor spend to budget. Commissioning & Qualification
• Take part in SAT, commissioning, and IQ/OQ alongside the OEMs and CQV team; this is how you learn the equipment.
• Support equipment PQ, sterilization validation, and cleanroom certification.
• Maintain equipment in a validated state through change control and requalification. Safety
• Own site safety for employees, contractors, and visitors. Quality, Documentation & Inspection Readiness
• Engineering and facility work compliant with 21 CFR 210/211 and FDA sterile drug cGMP.
• Draft engineering and maintenance SOPs for Quality review and approval; support deviations, root-cause investigations, and CAPAs in MasterControl, in partnership with Quality.
• Maintain equipment manuals, warranties, certificates of occupancy and insurance, and vendor contracts in one organized system.
• Help arrange and prepare for facility inspections, including fire marshal, insurance, utility, FDA, and client inspections, and represent facilities and engineering during them. Communication
• Timely updates on equipment status, maintenance windows, vendor schedules, and production or compliance risks; regular reporting to leadership on equipment, calibration compliance, safety, and spend. Required Qualifications Education & Experience
• With a bachelor's degree in engineering: 7+ years of relevant or directly transferable engineering, maintenance, or facilities experience.
• Without a bachelor's degree in engineering: 10+ years combined of trade school and hands-on experience in engineering, maintenance, facilities, or a skilled trade (including military technical service). Technical Experience
• Sterile manufacturing background: hands-on experience in a sterile cGMP manufacturing environment, or OEM field service on sterile manufacturing equipment (5+ years for candidates without an engineering degree). Veterans with military technical service, such as Navy nuclear, qualify with GMP manufacturing experience.
• Hands-on experience with at least two of the following: WFI/PW, cleanroom HVAC, autoclaves or washers, and automated filling equipment.
• Exposure to SAT, commissioning, or IQ/OQ is helpful; deep validation experience is not required.
• Demonstrated hands-on repair and maintenance work, not purely supervisory or administrative experience.
• Experience managing equipment vendors and facilities contractors on site. Knowledge, Skills & Abilities
• Mechanical and electrical troubleshooting, including reading P&IDs and schematics.
• CMMS experience.
• Inspection-ready GMP documentation.
• Industrial safety program knowledge.
• An eye for quality work: can tell a well-done repair from a rushed one.
• Organized, detail-oriented, and trustworthy with security and building access.
• Strong written and verbal communication. Preferred
• Equipment-maker (OEM) field service background in filling, inspection, WFI, or sterilization equipment (strongly preferred).
• Experience at a small or startup sterile cGMP manufacturer or CDMO.
• New-facility commissioning experience.
• PLC/HMI troubleshooting experience.
• A 2-year technical or vocational degree in electrical, HVAC, or construction management.
• Experience evaluating vendor and service proposals.
• Current experience with Blue Mountain RAM (strongly preferred), Rees Scientific EMS, MasterControl QMS, or Fedegari washers/autoclaves.
• Local candidates who know Triangle-area HVAC, electrical, plumbing, and cleaning vendors.
• Seeking a stable, long-term role in one location.

Direct Reports None; manages outside contractors and vendors. Role may expand in scope and title after commercial launch. On-Call & Emergency Response On-call for after-hours facility and equipment emergencies, including freezer/cooler temperature excursions (monitored through the Rees Scientific EMS), HVAC and utility failures, and security alarms. Working Conditions & Physical Requirements On-site manufacturing, utility, and warehouse environment with periodic office work. Requires frequent standing, walking, climbing, reaching, stooping, kneeling, and crouching, including ladders and work in mechanical and utility rooms. Performs repairs with hand and power tools. Occasional lifting of up to 50 lbs. Aseptic gowning into classified cleanroom areas as needed, especially to access equipment. Additional Requirements

• Valid driver's license for supply runs and vendor and site visits.
• Must pass a background check and drug screen.
• Basic computer skills: email, purchase orders and invoices, and a work order system. Success Metrics 90 Days
• Integrated into the Company's team and proactively solving problems and improving the facility.
• All GMP assets loaded in Blue Mountain RAM, with PM and calibration schedules current.
• Spare parts stocked for filler, inspection, WFI, autoclave, and HVAC.
• All keys, access credentials, and critical documents (manuals, warranties, certificates) held and inventoried.
• Cleaning, waste, scrub laundry, and service contracts active.
• Visitor and contractor sign-in procedure in place and enforced.
• Pest control program fully implemented and compliant with SOPs.
• Site safety assessment completed, with gaps in remediation. 6 Months
• Core engineering and maintenance SOPs drafted and submitted to Quality for approval.
• Vendor contracts reviewed and, where beneficial, consolidated or renegotiated.
• Facility passes a walk-through inspection (fire marshal, insurance, or internal audit) with no material findings on housekeeping, security, or documentation.
• Freezer/cooler and scrub supply systems running with zero stockouts or missed alarms.
• Helping fill the next round of positions and integrating new employees.

How to Apply Submit your résumé and a half-page summary of a failure you personally diagnosed and resolved on a WFI system, HVAC system, autoclave, or filling line. The interview process includes a technical discussion, a tour of the facility, and an on-site practical exercise. Equal Opportunity An equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by law.

Pay:

$115,000.00 - $130,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person