Engineer II, Manufacturing Engineering

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

Job Content Key Areas of accountability/responsibility

• Support at technology/process transfer.
• Supports introduction new equipment.
• Design and preparing production documentation.
• Perform deviation investigations management (as part of first line trouble shooting) to resolve Root Cause and to prevent reoccurrence.
• Lead continuous improvement projects – change controls (e.g. due to outcome of process/equipment Kaizens, CAPA and or Audit Findings)
• Perform batch documentation review.
• Represent Operations in the Customer Core Teams to assure the above-mentioned focus areas.
• Supports in training of Operations teams.
• Support Production Execution and Batch Disposition.