API Manufacturing Associate I (Night Shift)

Location: Onsite in Lexington, Massachusetts or Clayton, North Carolina, United States; night shift

Company

Novo Nordisk operates pharmaceutical manufacturing facilities producing active pharmaceutical ingredients for oral and injectable treatments.

What you will do

• Operate, monitor, and control highly automated API manufacturing equipment and processes.
• Execute production schedules and review electronic batch records in real time for SOP and cGMP compliance.
• Set up equipment and load or unload products from trucks, tankers, and ISO containers.
• Participate in qualification, validation, environmental monitoring, and cleanroom activities.
• Troubleshoot equipment issues, support maintenance activities, and help restore lost functions.
• Follow safety and environmental procedures while maintaining accurate production documentation.

Requirements

• High school diploma or equivalent required; an associate degree or higher in technology, science, or engineering is preferred.
• Computer literacy, including operation of computer-driven manufacturing equipment and Microsoft Office, required.
• Ability to read and understand complex product documentation and SOPs with close attention to detail.
• Knowledge of cGMP manufacturing and pharmaceutical production processes required; basic biology or chemistry knowledge preferred.
• Ability to perform material handling tasks safely, use material handling equipment, and troubleshoot basic mechanical components.
• Ability to work onsite for up to a 12-hour shift, handle equipment or supplies weighing up to 33 pounds, and work around hazardous materials, elevated heights, loud noise, and potentially confined or cold environments.

Nice to have

• At least two years of manufacturing experience in an FDA-regulated environment.
• BioWork, military, vocational, or equivalent industrial training.
• Experience with systematic, data-driven problem solving, event response, equipment maintenance, work permits, or Lock Out Tag Out systems.

Culture & Benefits

• Paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an individual company match option.
• Paid parental and family medical leave, life and disability insurance, and tuition assistance.
• Annual performance bonus and access to Novo Nordisk-marketed pharmaceutical products.