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 life-changing careers, and 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 Responsible for validation activities where in-depth analysis, authoring protocols, teamwork and flexibility are required. Responsible to carry out validation activities such as DQ, IQ, OQ, PQ, requalification, and utilities. Relationships Reports to Senior Tech Support Manager. Essential Functions + Primary responsibilities include validation protocol execution (DQ, IQ, OQ, PQ), data analysis and final report preparation for utilities, equipment and instrumentation + Serve as Operation Responsible (OR) and support Change Control activities to include: development, approval, and execution of department change control activities + Maintain effective communication and ensure alignment in coordination with appropriate teams + Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities + Ensure systems and processes are validated as well as change control activities for systems are completed in a compliant manner in accordance with FDA, EU and NN requirements + Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations + Complete accurate and timely assessments associated with change control activities + Support validation of new and existing equipment, processes and instrumentation as needed + Write and review protocols, summary reports and other documentation associated with validations + 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. Ability to travel up to 10% of the time. % can change on a case-by-case basis based on the role. Qualifications + Bachelor’s Degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required + May consider an associate’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university with a minimum of five (5) years of validation experience in a cGMP regulated industry required + Minimum of three (3) years of validation experience in a cGMP regulated industry required + Demonstrated understanding of the following: concepts of validation, change control processes, root cause analysis techniques, cGMP documentation practices, cGMP regulations, GMP and other industry standards pertaining to validation required + Demonstrated understanding of technical requirements for validation and biopharmaceutical equipment, facilities and/or instrumentation required + Excellent communication skills, both written and verbal required + Demonstrated ability to be self-motivated, trustworthy, work in a high-paced environment, team oriented, innovative, and committed required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. 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. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.