What are the responsibilities and job description for the Associate Process Engineer - API position at BioSpace?
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
Provide routine support & troubleshooting for the manufacturing facility. Primary tasks: Provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.
Relationships
Reports to Manager or Senior Manager.
Essential Functions
Support development of design & requirement specifications documents
Support quality of equipment & processes
Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)
Participation in the creation of a project cGMP Statement
Create & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
Own self development and partner with manager for clear understanding of development needs for desired career path
Input & review to Process FMECA’s for the Process tracks
Participation in design work shops with engineering suppliers
Input & review of Process Module Diagrams, & Process Flow Diagrams
Input & review of Process Scheduling & Capacity Calculations
Support package in maintaining schedule adherence
Ensure coordination & collaboration between project & other site stakeholders
Gather & ensure knowledge transfer to project from DK sponsor site
Follow all safety & environmental requirements in the performance of duties
Other duties 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
Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with a minimum of two (2) years of engineering or technical experience required, preferably in a GMP regulated environment
May consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
A minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environment
Experience with design of requirements documents a plus
Experience working in a GMP regulated environment preferred
Knowledge about requirements/expectations of regulatory authorities e.g. FDA a plus
Experience with Process Control Systems a plus
Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus
Ability to provide support for a 24/7 operational business required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
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
Provide routine support & troubleshooting for the manufacturing facility. Primary tasks: Provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.
Relationships
Reports to Manager or Senior Manager.
Essential Functions
Support development of design & requirement specifications documents
Support quality of equipment & processes
Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)
Participation in the creation of a project cGMP Statement
Create & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
Own self development and partner with manager for clear understanding of development needs for desired career path
Input & review to Process FMECA’s for the Process tracks
Participation in design work shops with engineering suppliers
Input & review of Process Module Diagrams, & Process Flow Diagrams
Input & review of Process Scheduling & Capacity Calculations
Support package in maintaining schedule adherence
Ensure coordination & collaboration between project & other site stakeholders
Gather & ensure knowledge transfer to project from DK sponsor site
Follow all safety & environmental requirements in the performance of duties
Other duties 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
Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with a minimum of two (2) years of engineering or technical experience required, preferably in a GMP regulated environment
May consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
A minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environment
Experience with design of requirements documents a plus
Experience working in a GMP regulated environment preferred
Knowledge about requirements/expectations of regulatory authorities e.g. FDA a plus
Experience with Process Control Systems a plus
Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus
Ability to provide support for a 24/7 operational business required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
