Facilities Engineer I - Black Utilities - PS AM 2

Novo Nordisk • Clayton, NC

8d • Onsite

About The Position

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. The purpose of this position is to maintain and optimize all black 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.

Requirements

• 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 black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, HVAC. Prior ownership/work experience preferred
• Knowledgeable in clean utilities system to include: WFI, pure water, clean steam, process air, vacuum, electrical a plus
• 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

Nice To Haves

• Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
• Prior ownership/work experience preferred
• Knowledgeable in clean utilities system to include: WFI, pure water, clean steam, process air, vacuum, electrical a plus
• 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

Responsibilities

• Maintain and improve system specifications for black 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 for black utilities

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level