Process Engineer Associate / I - API

The Position (Routine support & troubleshooting for the manufacturing facility)
- Provide input, review & approve design and requirement documents
- Provide input, review & approve technical specifications
- Support development of design & requirement specifications documents
- Support quality of equipment & processes
- Support creation of process track risk assessment documents (e.g., Requirement Risk Assessments (RRAs))
- Participate in creation of a project cGMP Statement
- Create & participate in Quality Risk Management (QRM) risk assessments (e.g., Closed-Process, Cross-Contamination, Contamination & Facility flows)
- Own self-development; partner with manager to understand development needs for desired career path
- Input & review Process FMECA’s (Process tracks)
- Participate in design workshops with engineering suppliers
- Input & review Process Module Diagrams and Process Flow Diagrams
- Input & review Process Scheduling & Capacity Calculations
- Support package in maintaining schedule adherence
- Ensure coordination and collaboration between project and other site stakeholders
- Gather and ensure knowledge transfer to the project from DK sponsor site
- Follow all safety and environmental requirements; other duties as assigned

Physical Requirements
- Move equipment/supplies up to 33 lbs; operate/inspect equipment with hands; strap/unstrap pallets
- Be on your feet up to a 12-hour shift; may require corrected vision and color vision
- Occasionally ascend/descend ladders and work at elevated heights; may work around hazardous/odorous materials; may wear latex gloves
- May perform critical work in extremely cold environments; work in confined spaces for inspection; loud noise environments with hearing protection
- May require motorized vehicle license and operate a motorized vehicle

Qualifications
- Bachelor’s degree in Engineering, Science, or relevant technical field (required)
- OR Associate’s degree + minimum 2 years engineering/technical experience (preferred in GMP environment)
- OR High school diploma/equivalent + 4 years engineering/technical experience (preferred in GMP environment)
- Minimum 1 year engineering/technical experience preferred (preferably in GMP environment)
- Plus: experience with design of requirements documents; GMP regulated environment; knowledge of regulatory authority expectations (e.g., FDA)
- Plus: Process Control Systems experience; ability to build networks and facilitate cross-organizational knowledge sharing
- Required: ability to provide support for a 24/7 operational business

What We Offer You
- Leading pay and annual performance bonus
- Paid time off including 14 paid holidays
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus individual company match option
- Family-focused benefits: 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

Application Instructions
- For special assistance/accommodations to apply: call 1-855-411-5290 (accommodation requests only).