API Manufacturing Associate I

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. Our North Carolina operations include three pharmaceutical manufacturing facilities responsible for different steps in our injectable and oral treatment supply chains. The newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC, spans 825,000 square-feet of state-of-the-art equipment and houses Fermentation, Recovery, and Purification processes for producing ingredients used in Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals passionate about their work.

About the Role

Operate API manufacturing equipment to achieve production goals.

Reports to Shift Manager, Operations – API.

Responsibilities

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

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Routinely operates and inspects manufacturing equipment using hands
• Strap and 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 and/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 and operate a motorized vehicle based on the role

Requirements

• High school graduate or equivalent required
• 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 an FDA-regulated environment preferred
• Experience demonstrating a systematic approach to problem-solving and troubleshooting based on data and facts; actively participated in and driven event response activities
• Documented problems and worked on ensuring rapid resolution and preventing recurrence preferred
• Experience following SOPs to perform tasks and raising issues if errors are found preferred
• Experience following established safety guidelines when performing tasks preferred
• Computer literacy, including ability to operate computer-driven manufacturing/production equipment and efficient use of Microsoft Office suite programs required
• Ability to read and understand complicated product documentation and standard operating procedures with attention to detail required
• Ability to perform basic material handling tasks, safely and effectively use material handling equipment required
• Ensure compliance with corporate/local SOPs, regulations, and ISO standards required
• General knowledge in cGMP manufacturing and production processes associated with pharmaceutical companies required
• Basic knowledge of biology/chemistry preferred
• Mechanical aptitude, ability to use tools to perform tasks, basic troubleshooting of mechanical components and systems preferred
• Experience working with work permits/Lock Out Tag Out systems preferred

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 and 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards