API Manufacturing Associate I

Novo Nordisk; Clayton (NC); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Performance bonus

14 paid holidays

Health/Dental/Vision insurance

401K match

Parental & family leave

Product discounts

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk in Clayton, NC is seeking a Manufacturing Technician to operate API manufacturing equipment and help meet production goals in a GMP-controlled environment. The role emphasizes safety, documentation, and real-time batch record review, with training and qualification activities as required.

The position offers comprehensive benefits and opportunities for professional growth within a global healthcare leader.

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 preferred
• Minimum two years of manufacturing experience in FDA regulated environment preferred
• Systematic problem solving & troubleshooting based on data; rapid resolution and prevention preferred
• Experience following SOPs to perform tasks and raise issues if errors are found preferred
• Experience following established safety guidelines when performing tasks preferred
• Computer literacy including Microsoft Office suite programs required
• Ability to read and understand complicated product documentation and SOPs with attention to detail required
• Ability to perform basic material handling tasks and use handling equipment
• Ensure compliance with SOPs, regulations & ISO standards
• General knowledge in cGMP manufacturing & production processes
• Basic knowledge of biology/chemistry preferred
• Mechanical aptitude and basic troubleshooting of mechanical components & systems preferred
• Experience with Lock Out Tag Out systems preferred

Responsibilities

• Work in a safe and environmentally responsible manner
• Follow GMP documentation & product quality instructions
• Review SOPs and other documents as required
• Real time review of electronic batch records ensuring compliance to SOPs & cGMP
• 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
• Maintain clean room areas and perform environmental monitoring as required
• Other accountabilities, as assigned

Skills

SOP adherence

Safety guidelines

Attention to detail

Mechanical aptitude

Troubleshooting basics

Reading product docs

Microsoft Office

Education

High school diploma

Associate or higher in Tech/Science/Engineering

BioWork or equivalent training

Tools

Microsoft Office suite

Production equipment operation

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-marketed 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.