Novo Nordisk · 6 hours ago
Process Engineer - Associate / I API
Clayton, NC
Full-time
Onsite
Entry Level
1+ years expNovo Nordisk is a leading company in diabetes care, improving the quality of life for millions worldwide. The Process Engineer - Associate / I API will provide routine support and troubleshooting for the manufacturing facility, focusing on design and technical specifications.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide routine support & troubleshooting for the manufacturing facility
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
Qualification
Required
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
Preferred
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
Benefits
Leading pay and annual performance bonus for all positions
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
Company
Novo Nordisk
Novo Nordisk is a healthcare company that produces and distributes insulin and other diabetes drugs to treat chronic diseases.
10001+ employees
H1B Sponsorship
Novo Nordisk has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (21)
2023 (13)
2022 (10)
2021 (9)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$22M2018-12-05Post Ipo Equity· $22M
1981-07-09IPO
Leadership Team
Lars Fruergaard Jørgensen
President and CEO
Lars Sorensen
President & CEO
Recent News
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Company data provided by crunchbase