Associate Process Engineer - API (Recovery)

BioSpace; Clayton (NC); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Paid holidays

Health & dental insurance

401K with company match

Tuition assistance

Life & disability insurance

Parental leave

Job summary

Novo Nordisk in Clayton, NC is seeking an engineer to provide routine support and troubleshooting for the manufacturing facility. Core duties include input, review and approval of design and requirement documents, plus technical specifications.

The role reports to a Manager or Senior Manager and supports design, risk assessments, and process diagrams to keep projects on track. Candidates should have an engineering or scientific degree, GMP experience preferred, and be prepared for a 24/7

Qualifications

• Bachelor’s degree in engineering, science or a relevant technical field.
• Associate’s degree with 2+ years engineering/technical experience in GMP preferred.
• High school diploma with 4+ years engineering/technical experience preferred.
• Minimum 1 year of engineering/technical experience, GMP preferred.
• Experience designing requirements documents is a plus.
• GMP experience is preferred.
• Familiarity with FDA or regulatory expectations is a plus.
• Experience with Process Control Systems is a plus.
• Proven ability to network and share knowledge across teams is a plus.
• Ability to support a 24/7 operation is required.

Responsibilities

• Support development of design and requirement specifications.
• Assist in quality of equipment and processes.
• Participate in risk assessments and QRM activities.
• Contribute to project cGMP documentation.
• Review Process FMEA and process diagrams.
• Coordinate cross-functional collaboration across site stakeholders.
• Support knowledge transfer from sponsor sites.
• Ensure compliance with safety and environmental requirements.

Education

Bachelor’s Degree in Engineering, Science, or relevant technical field

Associate’s Degree in Engineering, Science, or relevant field

High School Diploma with 4+ years engineering/technical experience

1+ year engineering/technical experience in GMP environment

Experience with design of requirements documents

Experience in GMP regulated environment

Knowledge of regulatory authority expectations (FDA)

Experience with Process Control Systems

Networking and cross-functional collaboration

Ability to support 24/7 operations

Tools

Process Control Systems

Job description

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.

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 colour 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.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.