Facilities Engineer II - Clean Utilities - PS AM

BioSpace; Clayton (NC); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Leading pay & annual bonus

Paid time off 14 holidays

Health/Dental/Vision from day one

401K with company match

Parental & family leave programs

Product samples access

Tuition assistance

Life & Disability Insurance

Referral awards

Job summary

Novo Nordisk in Clayton, NC is seeking a Facilities Engineer to maintain and optimize clean utilities systems at the DFP-US site. You will write specifications, review designs, install equipment, and lead commissioning, qualification, SOP development, and maintenance programs.

The role requires 5–8+ years in manufacturing, familiarity with cGMP utilities, and strong collaboration with engineering teams to meet safety, quality, and schedule targets.

Qualifications

• Bachelor's degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience.
• 5–8+ years engineering experience in a manufacturing facility, with knowledge of operations, maintenance & design of cGMP utilities.
• Experience in regulated environments (FDA, cGMP, OSHA) is preferred.
• Knowledge of clean utilities systems (WFI, clean water, chilled water, clean steam, process air, electrical).
• Knowledge of black utilities systems (chilled water, plant steam, process air, vacuum, wastewater, HVAC).
• Ability to read/review CAD drawings and understand P&ID, HVAC, Electrical systems.

Responsibilities

• Maintain and improve system specifications for clean utilities.
• Provide technical support for site projects as required.
• Adhere to quality and environmental regulations within area of responsibility.
• Support development of Facilities Technicians.
• Continuous process improvement using LEAN concepts.
• Maintain standards for procedures and maintenance plans.
• Work safely and comply with environmental requirements.

Skills

Project management

Process engineering

cGMP utilities knowledge

Regulatory compliance

CAD / P&ID reading

Cross-functional collaboration

Maintenance planning

Education

Bachelor's degree in Mechanical, Electrical or Chemical Engineering

Tools

CAD

UR S

FAT

SAT

Job description

About The Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

About The Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What We Offer You

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

The Position

The purpose of this position is to maintain and optimize all clean utilities systems for the DFP-US facility. Responsibilities include but are not limited to: writing/reviewing specification; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders. All activities are aligned with Environmental Health & Safety (EHS) program requirements.

Relationships

Reports to Manager, Facilities Maintenance and Engineering.

Essential Functions

• Maintain and improve system specifications for clean utilities
• Provide additional technical support for site project execution as required
• Adhere to all Quality & environmental regulations within area of responsibility
• Support technical development of Facilities Technicians
• Continuous process improvement using cLEAN® concepts
• Maintain & establish standards for procedures & maintenance plans
• All safety & environmental requirements in the performance of duties
• System owner/expert and support all design, installation, commissioning, qualification, training activities

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid drivers license.

Qualifications

• Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
• 5-8+ years engineering experience in a manufacturing facility. Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
• Knowledgeable in clean utilities systems to include: WFI, pure water, chilled water, clean steam, process air, electrical. Prior ownership/work experience required
• Knowledgeable in black utilities systems to include: chilled water, plant steam, process air, vacuum, waste water, cryogenic storage, HVAC preferred
• Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems preferred
• Understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred
• Computer literacy with associated systems preferred
• Proven expertise in planning/organization/execution of project & maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.