Novo Nordisk
Durham, NC
About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes obesity. 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. 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 contribute to the establishment of all utilities systems for the OFP site Durham. Responsibilities include, but are not limited to, writing/reviewing specifications; design reviews; equipment installation; commissioning qualifications; SOP development; maintenance development training management of cost, quality schedule within area of responsibility. Establish maintain positive working relationship with internal external engineering team stakeholders. Accountable to ensure all activities are aligned with Environmental Health Safety (EHS) program requirements. Relationships Reports to Senior Manager – OFP. Essential Functions Create maintain system specifications for black clean utilities Support all design, installation, commissioning, qualification, training activities for black clean utilities 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 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 mechanical, electrical, or chemical engineering or an equivalent combination of education industry experience required With an Associate’s degree in engineering field of study, must have a minimum of six (6) years internal NN experience in clean black utilities or similar systems required Two (2) years of engineering experience in a manufacturing facility preferred Knowledge experience in the operations, maintenance design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred Knowledgeable in black utilities system to include chilled water, plant steam, compressed air, vacuum wastewater management a plus Knowledgeable in clean utilities system to include process water, clean steam, process air, vacuum cryogenic storage a plus Ability to read/review design drawings (CAD) with a basic understanding of P ID, HVAC electrical systems preferred Understanding of technical documents such as URS, SAT, FAT, validation protocols a plus Understanding of complicated product documentation standard operating procedures with attention to high-level concepts a plus Computer literacy with associated systems preferred Ability to plan, coordinate