API Manufacturing Associate I (Night Shift)

About the Role

Operate API manufacturing equipment to achieve production goals in Novo Nordisk’s state-of-the-art Active Pharmaceutical Ingredients (API) facility in Clayton, NC. This 825,000 square-foot facility houses Fermentation, Recovery, and Purification processes for the production of ingredients for Novo Nordisk’s innovative oral products.

You’ll join a global network of manufacturing professionals passionate about improving the quality of life for millions of people worldwide.

Responsibilities

• Operate, monitor, and control highly automated API manufacturing processes and systems.
• Follow instructions listed in GMP documentation and product quality standards.
• Perform real-time review of electronic batch records to ensure compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
• Manage individual training plans and participate in qualification and validation activities.
• Execute the production schedule to meet production goals.
• Load and unload product from trucks, tankers, and ISO containers.
• Utilize investigation skills during troubleshooting and assist in equipment maintenance, including predictive and preventative maintenance.
• Maintain clean room areas and perform environmental monitoring as required.
• Perform critical job functions in compliance with safety and environmental standards.
• Other accountabilities as assigned.

Physical Requirements

• Move equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operate and inspect manufacturing equipment using hands.
• Strap and unstrap pallets using hands.
• Stand for up to a 12-hour shift.
• May require corrected vision to 20/20 or 20/25 and/or color vision based on role.
• Occasionally ascend/descend a ladder and work at elevated heights.
• Occasionally work around odorous and/or hazardous materials.
• May be required to wear latex gloves.
• May perform critical job functions in extremely cold work environments.
• May position oneself within confined spaces for inspection.
• Ability to work in loud noise environments with hearing protection.
• May be required to secure a motorized vehicle license and operate a motorized vehicle.

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 rapid resolution and prevention of 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.
• Generous paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective day one.
• Guaranteed 8% 401K contribution plus individual company match option.
• 14 weeks paid parental leave and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition assistance.
• Life and disability insurance.
• Employee referral awards.