API Manufacturing Associate I

BioSpace; Clayton (NC); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Performance bonus

Paid time off

Health insurance

401(k) with match

Parental leave

Tuition assistance

Life & disability insurance

Referral awards

Job summary

Novo Nordisk's API manufacturing facility in Clayton, NC is part of a global diabetes care leader. The role operates automated API production equipment, ensuring production goals while adhering to cGMP and SOPs.

The position reports to the Shift Manager, Operations – API and requires safety-minded, data-driven problem solving and teamwork. We offer competitive pay with annual performance bonus, comprehensive benefits from day one, 401(k) with company match, and generous PTO, parental leave,

Qualifications

• High school diploma or equivalent.
• Associate's Degree or higher in Tech, Science, or Engineering preferred.
• BioWork or equivalent industrial training with experience preferred.
• Minimum two years of manufacturing experience in FDA-regulated environment.
• Data-driven problem solving and active event response experience preferred.
• Follow SOPs and safety guidelines; read and apply SOPs accurately.
• Computer literacy; operate computer-driven equipment and MS Office.
• Read and interpret complex product documentation and SOPs.
• Basic material handling skills and use of handling equipment.
• Knowledge of cGMP and ISO standards.

Responsibilities

• Work in a safe and environmentally responsible manner.
• Follow GMP documentation and ensure product quality.
• Review SOPs and related documents as required.
• Real-time review of electronic batch records for cGMP compliance.
• Manage individual training plans.
• Participate in qualification and validation activities.
• Setup, operate, monitor, and control automated processes and systems.
• Load and unload product from trucks and ISO containers.
• Execute production schedules to meet goals.
• Support troubleshooting and equipment maintenance.
• Maintain cleanroom areas and conduct environmental monitoring.
• Other duties as assigned.

Skills

Manufacturing

GMP

SOPs

cGMP

Troubleshooting

Documentation

Safety

Computer literacy

Reading docs

Material handling

ISO standards

Biology/chemistry basics

Mechanical aptitude

Lock Out Tag Out

Education

Associate's Degree or higher in Tech/Science/Engineering

BioWork or equivalent training

High school diploma or equivalent

Tools

MS Office

Manufacturing control systems

Job description

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. 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-markated pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

The Position

Operate API manufacturing equipment to achieve production goals.

Relationships

Reports to Shift Manager, Operations – API.

Essential Functions

• 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

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 colour 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.

Qualifications

• 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 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
• Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs 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
• 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
• We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.