Maintenance Engineer I (Instrumentation & Controls)
Initial Therapeutics, Inc.
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 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 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 and Coach & mentor members of the maintenance team. This Maintenance Engineer will have a special focus on Instrumentation and Controls to support the design, development, implementation, and maintenance of control systems and instrumentation for industrial and process facilities. The ideal candidate will have experience with PLCs, SCADA/DCS systems, field instrumentation, and process automation in industries such as manufacturing, energy, water treatment, pharmaceuticals, or oil & gas. 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 drivers 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 mechanical systems operations, RCA, RCM, PHA, 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 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. #J-18808-Ljbffr Initial Therapeutics, Inc.
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