Process Engineer - Associate / I API

Novo Nordisk • Clayton, NC

2d • Onsite

About The Position

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.

Requirements

• 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
• Ability to provide support for a 24/7 operational business required

Nice To Haves

• 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

Responsibilities

• Provide routine support & troubleshooting for the manufacturing facility.
• Provide input, review & approve design & requirement documents
• Provide input, review & approve technical specifications
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level