API Manufacturing Associate I

Novo Nordisk • Clayton, NC

2d • Onsite

About The Position

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 Operate API manufacturing equipment to achieve production goals.

Requirements

• High school graduate or equivalent required
• Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
• Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
• Ensure compliance with corporate/local SOPs, regulations & ISO standards required
• General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
• Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required

Nice To Haves

• Associate's Degree or higher in Tech, Science, or Engineering preferred
• BioWork or equivalent industrial, military or vocational training combined with experience preferred
• Minimum two (2) years of manufacturing experience in FDA regulated environment preferred
• 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
• Experience following SOPs to perform tasks & raising issues if errors are found preferred
• Experience following established safety guidelines when performing tasks preferred
• Basic knowledge of biology/chemistry preferred
• Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
• Experience working with work permits/Lock Out Tag Out systems preferred

Responsibilities

• Work in a safe & environmentally responsible manner
• Follow instructions listed in GMP documentation & product quality
• Review SOP’s & other documents, as required
• Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
• Manage individual training plan
• Participate in qualification & validation activities as required
• Setup, operate, monitor, & control highly automated processes & systems
• Load & unload product from trucks, tankers & ISO containers, as required
• Execute production schedule to achieve production goals
• Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
• Maintain clean room areas & perform environmental monitoring, as required
• Other accountabilities, as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees