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Associate Process Engineer – API, Recovery
Novo Nordisk. Provide routine support and troubleshooting for the manufacturing facility .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in engineering principles and quality risk management within a GMP regulated environment, with a strong focus on process documentation and cross-organizational collaboration.
Highest-signal resume keywords
Bachelor's Degree In EngineeringGMP Regulated Environment ExperienceProcess Control SystemsQuality Risk ManagementTechnical Documentation Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design Of Requirements DocumentsProcess FMECAProcess Flow DiagramsProcess Module DiagramsRisk AssessmentCapacity CalculationsQuality SupportTroubleshootingEquipment MaintenanceKnowledge Transfer
Soft Skills
CollaborationNetworkingCommunicationProblem-SolvingSelf-Development
Industry Keywords
CGMP StatementsRegulatory AuthoritiesFDA ComplianceManufacturing FacilitySafety Requirements
About the role
Key responsibilities & impact- Provide routine support and troubleshooting for the manufacturing facility
- Provide input, review, and approve design and requirement documents
- Provide input, review, and approve technical specifications
- Support development of design and requirement specification documents
- Support equipment and process quality
- Support creation of process-track risk assessment documents, including Requirement Risk Assessments
- Participate in creation of project cGMP Statements
- Create and participate in Quality Risk Management risk assessments, including Closed-Process, Cross-Contamination, Contamination, and Facility Flows
- Complete self-development activities and partner with the manager to understand development needs
- Provide input to and review Process FMECA documents
- Participate in design workshops with engineering suppliers
- Provide input to and review Process Module Diagrams and Process Flow Diagrams
- Provide input to and review Process Scheduling and Capacity Calculations
- Support package maintenance of schedule adherence
- Ensure coordination and collaboration between the project and site stakeholders
- Gather and ensure knowledge transfer to the project from the Denmark sponsor site
- Follow all safety and environmental requirements
- Perform 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
- 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 be considered
- High School Diploma or equivalent with four (4) years of engineering or technical experience may be considered
- A minimum of one (1) year of engineering or technical experience 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 and maintain networks and facilitate processes that encourage cross-organizational knowledge sharing a plus
- Ability to provide support for a 24/7 operational business required
- Ability to move equipment and/or supplies weighing up to 33 pounds
- Ability to be on feet for up to a 12-hour shift
- Ability to work around hazardous materials, loud noise, elevated heights, confined spaces, and extremely cold environments as required
- May be required to secure a motorized vehicle license and operate a motorized vehicle
Benefits
Comp & perks- Leading pay and annual performance bonus for all positions
- 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
- 14 weeks paid parental leave
- 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Opportunities, resources, and mentorship for career growth