Process Engineer

As a Process Engineer you will ensure successful ramp-up of the process tracks. Process expert role in developing the project. Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.

Accountabilities

• Support development of design & requirement specifications documents
• Ensure 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
• Creation & participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
• 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
• Gathering & ensure knowledge transfer to project from DK sponsor site
• Other duties or tasks, as assigned

Required Qualifications

• BA/BS in Science or Engineering (preferably Mechanical, Electrical, Chemical or Industrial), or an equivalent combination of education & related experience in a GMP environment for more than five (5) years.

Desired Qualifications

• Minimum of one (1) year of work-related engineering experience in Manufacturing, Design, Maintenance or Process Improvement
• Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)
• Proven expertise in planning/organization/execution of maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams

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