Operator I - Utility & RMS

Novo Nordisk

Clayton, NC

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 The purpose of the position is to operate utility and RMS process equipment to support API-US production. Responsibilities include operation of applicable equipment within the scope of the department. Other duties will be receiving materials, completing training and supporting quality financial goals for the site. Establish maintain positive working relationships with internal external stakeholders and ensure all activities are aligned with Environmental Health Safety (EHS) program expectations. Relationships Reports to Manager. Essential Functions Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems Identify and document system or operational anomalies for cause clearance to minimize downtime and ensure a safe working environment Maintain standards operational procedures for automated and manually operated systems Support consistent operation, maintenance response for all control systems (BMS, PCS, Life Safety) Support stakeholders as required for successful plant operations including maintenance and optimization activities Execute raw material movement and offload into process systems Execute site rounds and equipment inspections independently to ensure efficient and compliant operations Adhere to all Quality Environmental regulations Participate in systematic problem-solving efforts Manage individual training plan Perform routine cleaning and good housekeeping as needed for assigned areas Review electronic batch records real-time to ensure compliance to Standard Operating Procedures (SOPs) current Good Manufacturing Practices (cGMP) standards Follow 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. Strap unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour 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. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license operate a motorized vehicle based on the role. Qualifications High school graduate or GED required Bachelor’s Degree in a relevant field of study from an accredited university preferred BioWork certification or equivalent a plus Minimum of 6 months of related experience in regulated industry required Knowledge experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) a plus Experience demonstrating a systematic approach to problem solving troubleshooting based on data facts. Actively participated in driven event response activities. Documented problems worked on ensuring rapid resolution preventing recurrence preferred Basic knowledge of production utility systems or raw material handling such as: puri