Maintenance Engineer I

Novo Nordisk; Clayton (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual performance bonus

Generous paid time off

Health, Dental, Vision Insurance

401K contribution and match

Paid parental and family medical leave

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk in Clayton, NC, is seeking an experienced engineer to support maintenance activities for API production equipment. The role focuses on improving reliability and performance within the production environment.

Candidates should have a Bachelor's degree in engineering, with a minimum of three years of relevant experience, particularly in a pharmaceutical manufacturing setting. Responsibilities include leading maintenance improvement projects and ensuring compliance with maintenance standards.

Qualifications

• Minimum three (3) years of experience in utilities or process equipment maintenance.
• Experience working in a pharmaceutical manufacturing environment with cGMP requirements.
• Technical knowledge of mechanical systems operations and maintenance.

Responsibilities

• Lead and coordinate maintenance performance improvement projects.
• Support manufacturing and production teams to ensure maintenance compliance.
• Provide technical support to stakeholders to meet business goals.

Skills

Root Cause Analysis (RCA)

Troubleshooting

Continuous Improvement

Project Management

Excellent Communication Skills

Education

Bachelor's Degree in Engineering

Tools

SAP

CMMS

Job description

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.

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.

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

Support proper implementation & execution of maintenance activities for API production equipment & systems within DAPI‑US facility. Improve the reliability & performance of API operations tracks with respect to equipment/systems maintenance. Utilize a reliability centered mindset to maximize plant productivity, while maintaining equipment performance & longevity. Primary tasks include: Lead & coordinate maintenance performance improvement projects & initiatives. Support manufacturing & production support teams to ensure maintenance compliance. Provide technical support to the site & stakeholders to meet business goals. Coach & mentor members of the maintenance team.

Relationships

Reports to Senior Manager, Maintenance Support.

Essential Functions

• Write/review maintenance plans, specifications & SOPs


• Participate in equipment/system design reviews & support equipment installation, commissioning & qualifications


• Assist in maintaining quality & schedule within area of responsibility


• Establish & maintain positive working relationship with internal & external engineering & operations stakeholders


• Lead & provide technical support for investigation, troubleshooting & problem resolution of equipment & system operational issues


• Support development, implementation & improvement of equipment & systems maintenance plans during operation


• Continuous improvement: verify process equipment & satisfy design requirements/expectations


• Knowledge sharing with local & DK facilities


• Develop knowledge of risk assessment documents, such as requirements risk assessments (RRA's)


• Support the review & updating of engineering & specification documentation (process flow diagrams, P&IDs, user req specifications, etc.)


• Drive maintenance team adherence to PSM requirements & best practices


• Participate in the review & updating of process & system risk assessments


• Other accountabilities, as assigned

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 driver's license.

Qualifications

• Bachelor's Degree in engineering (preferred degree in maintenance, mechanical, chemical, electrical, bio‑process engineering), or equivalent industrial, military, or vocational training combined with experience required


• Minimum three (3) years of experience working directly in utilities or process equipment maintenance, or other directly related field required


• Demonstrated experience in plant operations & maintenance with proven knowledge in RCA, troubleshooting, problem resolution & continuous improvement preferred


• Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment a plus


• Six Sigma Green Belt certification or cLEAN 2-star desired a plus


• Demonstrated experience in maintenance processes & mechanical systems preferred


• Practical knowledge in the following areas: mechanical systems operations, root cause analysis (RCA), reliability centered maintenance (RCM), process hazard assessment (PHA), process safety management (PSM) & process improvement methodologies (Six Sigma, Lean Sigma) a plus


• 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 a plus


• Experience with using records control systems (SAP, CMMS or similar system) a plus


• Ability to read & understand equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings & other specialized documentation required


• Knowledge & understanding of technical documents such as URS, SAT, FAT, qualification & validation protocols a plus


• Experience using controls & control interfaces for PLC, PCS, BMS & DCS systems a plus


• Ability to independently apply engineering techniques & analysis within the discipline preferred


• Strong project management skills a plus


• Excellent oral & written communication skills preferred


• Proven expertise in developing/planning/coordinating maintenance activities & following up on results preferred


• Experienced in creating &/or revising work plans for complex problems being resolved by cross functional teams a plus

Equal Opportunity Employer

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

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.