API Manufacturing Associate I

Company: Novo Nordisk
Location: Clayton
Posted on: January 27, 2023

Job Description:

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and 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 12 weeks paid parental & 6 weeks paid family medical leave
* Free access to Novo Nordisk-marketed pharmaceutical products
* Tuition Assistance - reimbursement up to $10,000 annually
* Life & Disability Insurance
* Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

Position Purpose

Operate API manufacturing equipment to achieve production goals.

Accountabilities

* 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

Required Qualifications

* High school graduate or equivalent
* Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs
* Ability to read & understand complicated product documentation & standard operating procedures with attention to detail
* Ability to perform basic material handling tasks, safely & effectively use material handling equipment
* Ensure compliance with corporate/local SOPs, regulations & ISO standards
* General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies

Desired Qualifications

* AA/AS/AAS degree or higher in Tech, Science, or Engineering
* BioWork or equivalent industrial, military or vocational training combined with experience
* Minimum two (2) years of manufacturing experience in FDA regulated environment
* 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
* Experience following SOPs to perform tasks & raising issues if errors are found
* Experience following established safety guidelines when performing tasks
* Basic knowledge of biology/chemistry
* Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems
* Experience working with work permits/Lock Out Tag Out systems

Physical & Other Requirements

* Ability to move equipment and/or supplies weighing up to 50 lbs. within facility
* Ability to routinely operate & inspect manufacturing equipment using hands
* Ability to constantly position oneself to transfer materials within manufacturing environment
* Ability to frequently move about the building to access other personnel & operational areas
* Ability to move throughout facility to interact with other employees in the normal office & manufacturing environment
* Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
* Ability to ascend/descend a ladder to service equipment
* Ability to work atop elevated positions at heights
* Ability to secure a motorized vehicle license & operate motorized equipment
* Ability to work around odorous &/or hazardous materials
* Ability to perform critical job functions in extremely cold work environments
* Ability to work around mechanical equipment
* Ability to work hours as needed to support production including on call, some evenings &/or weekends
* Ability to position oneself within confined spaces for inspection, repair & maintenance of equipment
* Ability to work in loud noise environments with hearing protection
* Ability to travel internationally, as requested
* Ability to attain clean room gowning certification
* Ability to stand on feet up to 12 hours or longer, day or night

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.

Keywords: Novo Nordisk, Raleigh , API Manufacturing Associate I, Other , Clayton, North Carolina