Process Engineer

Responsibilities

• Evaluate equipment for recapitalization or BCP planning and provide implementation recommendations
• Develop documentation to support capital funding requests
• Provide technical input during equipment design and procurement, including review of datasheets and specifications
• Incorporate EHS considerations into proposals and design
• Support design and installation of new equipment, including fermentation/purification expertise
• Support Asset Delivery (C&Q) activities including User Requirements, Design Reviews, and Verification Strategy
• Execute Kneat test case execution
• Support BCP-related tasks such as spare parts assessments and procurement
• Support implementation of CAPAs, procedure updates, and change control generation
• Participate in investigations and problem-solving activities including Root Cause Analysis and FMEA
• Provide status updates to process teams and engineering leadership

Requirements

• Bachelor’s, Master’s, or Doctorate in Engineering
• Doctorate, OR Master’s + 2 years experience, OR Bachelor’s + 4 years experience
• Experience in Process Engineering, C&Q/Asset Delivery, and Kneat
• Experience supporting capital projects, equipment installation, and verification
• Familiarity with GMP/GLP and regulated documentation systems
• Experience with investigations, CAPAs, and structured problem-solving
• Strong technical writing and communication skills in English and Spanish

Preferred Qualifications

• Mechanical, Electrical, Industrial, or Chemical engineering background
• Experience with fermentation/purification systems
• Experience with automated and manual inspection equipment
• Knowledge of inspection technologies for parenteral or glass containers
• Ability to collaborate with cross-functional teams including Manufacturing, QA, and Automation

Benefits

• One-year assignment with possible extension