Verified Job
Manufacturing - Operations
API Manufacturing Associate I (Night Shift)
Manufacturing - Operations
#43174
Remote / WFH
Novo Nordisk
Job Description
API Manufacturing Associate I (Night Shift)
Facility: Manufacturing
Location: Clayton, NC, US
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
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.
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 color 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
Facility: Manufacturing
Location: Clayton, NC, US
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
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.
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 color 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
