Facilities Engineer I - Clean Utilities - PS AM 2

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Novo Nordisk in North Carolina seeks an engineer to maintain and optimize clean utilities systems at the DFP-US facility. You will write specifications, review designs, support installation and commissioning, and drive qualification, SOP development, and training in a regulated environment.

Responsibilities include managing cost, quality and schedule, collaborating with internal and external engineers, and ensuring EHS compliance across activities while promoting Lean improvements.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or equivalent.
• 2–5+ years engineering experience in a manufacturing facility with cGMP context.
• Experience with clean utilities (WFI, clean steam, process air) and safety standards.
• Ability to read CAD drawings and basic P&ID, HVAC, and electrical concepts.
• Familiarity with URS, FAT, Validation Protocols and regulatory expectations.

Responsibilities

• Maintain and improve system specifications for clean utilities.
• Support design, installation, commissioning, qualification and training activities.
• Provide technical support for site project execution with cross-functional teams.
• Adhere to Quality and environmental regulations within area of responsibility.
• Support development of Facilities Technicians and continuous process improvement.

Skills

Engineering experience

CAD

P&ID understanding

Regulatory knowledge

Education

Bachelor's in Mechanical Eng

Bachelor's in Electrical Eng

Bachelor's in Chemical Eng

Tools

CAD software

Job description

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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
• Support all design, installation, commissioning, qualification, training activities for clean utilities, as system expert/owner
• 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

Physical Requirements

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

Qualifications

• Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
• 2-5+ 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, clean steam, process air, electrical. Prior ownership/work experience preferred preferred
• Knowledgeable in black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage a plus
• Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems preferred
• Understanding 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

Equal Opportunity Statement

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

Equal Opportunity Employer

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.