Finished Production Maintenance Engineer II - IFP

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 12 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.
 

The Position

Lead the implementation and execution of maintenance projects for production equipment and systems. Work with the maintenance team to improve equipment/systems reliability and performance, ensure maintenance compliance, and provide technical expertise to maximize plant productivity while maintaining equipment performance and longevity. Must demonstrate ability to analyze data, troubleshoot technical issues, and stay up-to-date with the latest industry trends and technologies to ensure the success of maintenance activities and the organization. Mentor junior members of the maintenance team to ensure that projects are completed on time and within budget.

Relationships

Senior Manager.

Essential Functions

• Lead & coordinate maintenance performance improvement projects & initiatives
• Support manufacturing & production support teams to ensure maintenance compliance, to include providing technical support to the site and stakeholders to meet business goals
• Participate in the development and evolution of new or next-generation equipment, ensuring its alignment with the maintenance and reliability strategies
• 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 proactive positive working relationship with internal & external engineering & operations stakeholders
• Lead & provide technical support for investigation, troubleshooting & problem resolution of equipment & system operational issues
• Coach & mentor members of the maintenance team
• Support development, implementation & improvement of equipment & systems maintenance plans during operation
• Champion Continuous improvement: verify process equipment & satisfy design requirements/expectations
• Support 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
• Follow all safety and environmental requirements in the performance of duties
• 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 20/20 or 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 engineering (Maintenance, mechanical, chemical, electrical, bio-process engineering preferred) or related field of study from an accredited university required
  • May consider an Associate’s degree in Engineering technology (Maintenance, mechanical, chemical, electrical, bio-process engineering preferred) from an accredited university with a minimum of seven (7) years of experience working directly in utilities or process equipment maintenance, or other directly related field required
  • Minimum five (5) 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 required
• Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment preferred
• Six Sigma Green Belt certification or cLEAN® 2-star desired a plus
• Demonstrated experience in maintenance processes & mechanical systems required
• 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) 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 required
• Technical/process/functional knowledge of systems components maintenance & operation to include centrifugation, spray drying & chromatography a plus
• Experience with using records control systems (SAP, CMMS or similar system) preferred
• 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 preferred
• Experience using controls & control interfaces for PLC, PCS, BMS & DCS systems preferred
• Ability to independently apply engineering techniques & analysis within the discipline required
• Strong project management skills preferred
• Excellent oral & written communication skills preferred
• Proven expertise in developing/planning/coordinating maintenance activities & following up on results required
• Experienced in creating &/or revising work plans 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 recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.