Associate Process Engineer - API (Recovery)

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Novo Nordisk in Clayton, NC is seeking a qualified engineer to provide routine support and troubleshooting for the manufacturing facility. You will input, review and approve design and requirement documents and technical specifications to ensure compliant and efficient production processes.

The role emphasizes cGMP compliance, risk assessments, and collaboration with engineering suppliers and site stakeholders to maintain schedule and safety standards.

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

Responsibilities

• Support design and requirement documents input, review and approval.
• Review and approve technical specifications.
• Participate in creating project cGMP Statements and QRM risk assessments.
• Create and participate in Quality Risk Management (QRM) risk assessments.
• Coordinate with engineering suppliers and site stakeholders.
• Ensure schedule adherence and operational support for 24/7 manufacturing.

Skills

GMP regulated environment experience

Regulatory knowledge (FDA)

Cross-team collaboration

Education

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

Associate’s Degree in Engineering, Science, or relevant technical field of study

High School Diploma or equivalent with four years of engineering/technical experience

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.

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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 documentsSupport quality of equipment & processesSupport the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)Participation in the creation of a project cGMP StatementCreate & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flowsOwn self development and partner with manager for clear understanding of development needs for desired career pathInput & review to Process FMECA’s for the Process tracksParticipation in design work shops with engineering suppliersInput & review of Process Module Diagrams, & Process Flow DiagramsInput & review of Process Scheduling & Capacity CalculationsSupport package in maintaining schedule adherenceEnsure coordination & collaboration between project & other site stakeholdersGather & ensure knowledge transfer to project from DK sponsor siteFollow all safety & environmental requirements in the performance of dutiesOther 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 requiredMay 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 environmentMay consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environmentA minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environmentExperience with design of requirements documents a plusExperience working in a GMP regulated environment preferredKnowledge about requirements/expectations of regulatory authorities e.g. FDA a plusExperience with Process Control Systems a plusProven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plusAbility 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.