Pharmaceutical Operator - FFEx AP (Environmental Monitoring)

Pharmaceutical Operator - FFEx AP (Environmental Monitoring) Facility: Manufacturing Location: Clayton, NC, US 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 approximately 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 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 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 Life & Disability Insurance The Position Assist in developing the structure to aseptically operate Formulation, Wash/Sterilization, Filling, & media preparations through documentation, start‑up and validation activities for a new production facility. Relationships Reports to Manager. Essential Functions Review & author Job Instructions, SOP’s & other documents Assist in the start‑up and validation of new equipment Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring Assist maintenance team in the development of protocols for restoration of lost function, predictive & preventive maintenance Support Subject Matter Experts (SMEs) in the training process of fellow employees in areas of expertise, to include learning systems & equipment outside of area of expertise Follow all safety & environmental requirements in the performance of duties Other duties 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 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. 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 diploma or equivalent required Minimum two (2) years of experience in an FDA regulated environment required Aseptic processing experience required Isolator experience preferred Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required Expertise in planning/organizing, managing execution, checking results & revising work plan preferred 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 Novo Nordisk A/S