Operations Shutdown Area Specialist - API

About The Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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.

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

• 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

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

Plan & lead shutdown activities to ensure reliable equipment operations while also maximizing production time. Ensure the ongoing development & improvement of the department's shutdown process. Advocates for both production & maintenance.

Reports to Assoc Director, Operations

• Plan & execute maintenance, calibration, & project shutdowns in the department in collaboration with API-US stakeholders
• Coordinate closely with Production Management & Planners to effectively utilize planned or unplanned gaps in production to maximize maintenance, calibration, & project activities
• Collaborate with Maintenance Planning & process owners to set up maintenance preventive maintenance plans & calibration frequencies to ensure equipment reliability & compliance while maximizing time for production
• Support & drive key equipment & facility related projects within area
• Drive projects, initiatives & continuous improvement of the facility & equipment
• Ensure coordination & collaboration between API-US & other site stakeholders, primarily Production Support
• Gather & ensure knowledge transfer from similar production sites in Novo Nordisk
• Establish & maintain positive working relationship with internal & external engineering & operations stakeholders
• Establish standardized process using lean methodologies to drive culture of continuous improvement activities within area of responsibility
• Other accountabilities, as assigned

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 protection.

• Bachelor's Degree (pharmacology, engineering, biology) or equivalent combination of education & experience in a GMP regulated environment required
• Minimum of 5 (five) years of experience operating in a GMP regulated environment required
• Demonstrated experience in maintenance processes & mechanical systems preferred
• Technical/process/functional knowledge of utility systems components maintenance & operation including cooling & chilled water, plant steam (HP & LP), compressed air, clean steam & purified water preferred
• Technical/process/functional knowledge of specific equipment maintenance & operation including but not limited to pumps (centrifugal, PD, diaphragm, mag drive, other), heat exchangers, control valves, mixers, agitators & filtration preferred
• Technical/process/functional knowledge of API systems components maintenance & operation to include centrifugation, spray drying & chromatography. 5 preferred
• Experience with using records control systems (SAP, CMMS, or similar system) preferred
• Experience in utilizing Project Management processes & tools preferred
• Ability to plan complex activities involving multiple stakeholders. Proven ability to establish & maintain networks & facilitate processes that encourage cross…