Process Engineer - Associate / I API

Role Summary

Location: Clayton, NC. The Process Engineer - Associate / I API provides routine support and troubleshooting for Novo Nordisk's manufacturing facility. You will input, review, and approve design and requirement documents, and input, review, and approve technical specifications. Reports to Manager or Senior Manager.

Responsibilities

• 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

Qualifications

• Required: 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 required, preferably in a GMP regulated environment
• Required: High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
• Preferred: A minimum of one (1) year of engineering or technical experience, preferably in a GMP regulated environment
• Preferred: Experience with design of requirements documents
• Preferred: Experience working in a GMP regulated environment
• Preferred: Knowledge about requirements/expectations of regulatory authorities e.g. FDA
• Preferred: Experience with Process Control Systems
• Preferred: Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing
• Required: Ability to provide support for a 24/7 operational business

Additional Requirements

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operates & inspects manufacturing equipment using hands.
• Strap & unstrap pallets using hands.
• Must be able to be on your feet for up to a 12-hour shift.
• May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role.
• Occasionally ascends/descends a ladder. May be required to work at elevated heights.
• Occasionally works around odorous &/or hazardous materials.
• May be required to wear latex gloves.
• May perform critical job functions in extremely cold work environments depending on site.
• May position oneself within confined spaces for inspection if required of the role.
• Ability to work in loud noise environments with hearing protection.
• May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.