Novo Nordisk
Clayton, NC
About the Department At Novo Nordisk, we want to make a difference. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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 The purpose of this position is to lead maintenance and optimization of 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, leadership and mentoring of junior team members. All activities are aligned with Environmental Health Safety (EHS) program requirements. Relationships Reports to Manager, Facilities Maintenance and Engineering. Essential Functions Create maintain system specifications for black utilities Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert Provide additional technical support to project team as required Adhere to all Quality environmental regulations within area of responsibility Support technical development of Facilities Technicians after handover to LOB Continuous process improvement using cLEAN® concepts Maintain establish standards for procedures maintenance plans All safety environmental requirements in the performance of duties 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 Mechanical, Electrical or Chemical Engineering or equivalent combination of education experience required 8-15+ 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 Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, wastewater, cryogenic storage, HVAC. Demonstrated ownership and innovation of black utility systems required Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required Ability to read/review design drawings (CAD) with a basic understanding of P ID, HVAC, Electrical systems required Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred Thorough understanding of complicated product documentation standard operating procedures with attention to high-level concepts required Computer literacy with associated systems preferred Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes require