API Manufacturing Associate I

Novo Nordisk•Clayton, NC

14h•Onsite

About The Position

Operate API manufacturing equipment to achieve production goals at Novo Nordisk’s Active Pharmaceutical Ingredients facility in Clayton, North Carolina. The role supports production of ingredients for the company’s oral products and involves operating highly automated processes and systems while meeting safety, environmental, product-quality, and production requirements. The position reports to the Shift Manager, Operations – API.

Requirements

High school graduate or equivalent.
Experience demonstrating a systematic, data- and fact-based approach to problem-solving and troubleshooting.
Computer literacy, including the ability to operate computer-driven manufacturing or production equipment and efficiently use Microsoft Office programs.
Ability to read and understand complicated product documentation and standard operating procedures with attention to detail.
Ability to perform basic material-handling tasks and safely and effectively use material-handling equipment.
Ability to ensure compliance with corporate and local SOPs, regulations, and ISO standards.
General knowledge of cGMP manufacturing and production processes associated with pharmaceutical companies.
Physical ability to move equipment or supplies weighing up to 33 pounds, operate and inspect equipment with hands, strap and unstrap pallets, and remain on one's feet for up to a 12-hour shift.
May need corrected vision to 20/20 or 20/25, color vision, ability to climb ladders or work at elevated heights, work around odorous or hazardous materials, wear latex gloves, work in extremely cold environments or confined spaces, and work in loud environments with hearing protection, depending on the role.
May need to obtain a motorized vehicle license and operate a motorized vehicle, depending on the role.

Nice To Haves

Associate's degree or higher in technology, science, or engineering.
BioWork or equivalent industrial, military, or vocational training combined with experience.
At least two years of manufacturing experience in an FDA-regulated environment.
Experience participating in and driving event-response activities, documenting problems, and supporting rapid resolution and recurrence prevention.
Experience following SOPs to perform tasks and raising issues when errors are found.
Experience following established safety guidelines when performing tasks.
Basic knowledge of biology or chemistry.
Mechanical aptitude, ability to use tools to perform tasks, and basic troubleshooting skills for mechanical components and systems.
Experience working with work permits or Lock Out Tag Out systems.

Responsibilities

Work safely and in an environmentally responsible manner.
Follow GMP documentation and product-quality instructions; review SOPs and other documents as required.
Review electronic batch records in real time to ensure compliance with SOPs and current cGMP standards.
Manage an individual training plan and 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 the production schedule to achieve production goals.
Use investigation skills during troubleshooting and assist with equipment maintenance, including restoration of lost function and predictive and preventative maintenance.
Maintain cleanroom areas and perform environmental monitoring as required.
Perform other accountabilities as assigned.

Benefits

Leading pay and annual performance bonus for all positions.
Paid time off, including 14 paid holidays.
Health, dental, and vision insurance effective day one.
Guaranteed 8% 401(k) contribution plus an individual company match option.
Family-focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave.
Free access to Novo Nordisk-marketed pharmaceutical products.
Tuition assistance.
Life and disability insurance.
Employee referral awards.
Opportunities, resources, and mentorship for career growth.