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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 supporting manufacturing processes and quality assurance, with a strong focus on regulatory compliance and risk management. Proficient in collaborating with stakeholders and facilitating knowledge transfer in a GMP regulated environment.
Highest-signal resume keywords
Bachelor's Degree In EngineeringGMP Regulated Environment ExperienceProcess Control Systems ExperienceQuality Risk ManagementDesign Of Requirements Documents
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical Specifications ReviewProcess FMECAProcess Flow DiagramsProcess SchedulingRisk Assessment DocumentsEquipment InspectionManufacturing Equipment OperationKnowledge TransferDesign Workshops ParticipationSchedule Adherence
Soft Skills
CollaborationCommunicationProblem-SolvingSelf-DevelopmentStakeholder Coordination
Certifications & Qualifications
Motorized Vehicle License
Industry Keywords
CGMP StatementsRegulatory Authority RequirementsFDA ComplianceManufacturing Facility SupportHazardous Materials Handling
About the role
Key responsibilities & impact- Provide routine support and troubleshooting for the manufacturing facility
- Provide input to, review, and approve design and requirement documents
- Provide input to, 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
- 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 schedule adherence
- Coordinate and collaborate between projects and site stakeholders
- Gather and ensure knowledge transfer from the Denmark sponsor site to the project
- Follow all safety and environmental requirements
- Own self-development and partner with the manager on career development
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor's Degree in Engineering, Science, or relevant technical field from an accredited university by 6/30/2027 or within 12 months of application required
- Associate's Degree in Engineering, Science, or relevant technical field from an accredited university with a minimum of two years of engineering or technical experience may be considered
- High School Diploma or equivalent with four years of engineering or technical experience may be considered
- Ability to provide support for a 24/7 operational business required
- Ability to work on feet for up to a 12-hour shift
- Ability to move equipment or supplies weighing up to 33 pounds
- Ability to operate and inspect manufacturing equipment using hands
- Ability to work around hazardous materials, loud noise, cold environments, elevated heights, ladders, and confined spaces as required
- May be required to secure a motorized vehicle license and operate a motorized vehicle
- Experience with design of requirements documents is a plus
- Experience working in a GMP regulated environment preferred
- Knowledge of regulatory authority requirements, such as FDA, is a plus
- Experience with Process Control Systems is a plus
- Ability to establish and maintain networks and facilitate cross-organizational knowledge sharing is a plus
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