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Associate Process Engineer – API
Novo NordiskProvide engineering support for the manufacturing facility at Novo Nordisk. Responsible for development of design specifications, quality processes, and collaboration with engineering suppliers.
ATS Keywords
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Hard Skills
design documentstechnical specificationsquality risk managementrisk assessmentsprocess FMECAprocess flow diagramscapacity calculationsprocess control systemsGMP regulationsengineering experience
Soft Skills
collaborationcommunicationnetworkingknowledge transferself-developmenttroubleshootingcoordinationinput reviewparticipation in workshopssupport for operational business
Certifications & Qualifications
Bachelor's Degree in EngineeringBachelor's Degree in ScienceAssociate's Degree in EngineeringHigh School Diploma
Industry Keywords
cGMPFDArisk managementmanufacturing facilityengineeringtechnical experienceregulatory authoritiessafety requirementsenvironmental requirementsprocess tracks
About the role
Key responsibilities & impact- Provide routine support & troubleshooting for the manufacturing facility.
- Primary tasks: 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 workshops 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
Requirements
What you’ll need- Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
- Bachelor's degree in engineering/related field or anticipated Bachelor's degree in engineering/related field by 6/30/26 required, or within 12 months of application 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.
Benefits
Comp & perks- 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