Process Engineer II

Essential Functions

• Support commercial production and online troubleshooting for both the process and associated equipment.
• Design, develop, implement and, as needed, oversee systems to improve and sustain commercial manufacturing, cleaning, filling and packaging processes.
• Work collaboratively with a cross functional team (R&D, Quality, QC, Production, EHS, etc.) to ensure improvements align with required design and development process.
• Author supporting process development documents such as SOPs, IOQs, Batch Records, Protocols and Reports.
• Assist in Nonconformance and OOS investigations to drive to root cause and implement effective CAPAs to mitigate repeat events.
• Lead a cross functional team for implementation of new processes, systems, equipment, etc.
• Define, procure, install and qualify manufacturing equipment for commercial production.
• Lead continuous improvement projects for established products and systems.
• Represent projects technically for customer calls and meetings as projects progress through development.

Qualifications

• Bachelor's degree in Chemical Engineering.
• A minimum of 2 years of engineering experience in a manufacturing environment or similar required.
• Knowledge of equipment specification, qualification and automation required.
• Experience working in an ISO 13485 or FDA GMP environment preferred.
• Familiarity with process scale-up, optimization, cleaning and validation activities preferred.
• Expertise with procurement and maintaining production equipment preferred.
• LEAN / Six Sigma certification preferred.

What We Offer

• Great people and culture.
• Peer-to-peer recognition.
• Broader, hands-on work experience.
• Clean and modern equipment and labs.
• Fun company events.
• Competitive wages and generous year-end bonus.
• Comprehensive benefits:
  • 3 PPO medical plans with telemedicine, Rx, and vision.
  • 2 dental plans.
  • Healthcare, dependent care, and commuter flexible spending accounts.
  • 401(k) with company match.
  • Financial health and wellness with 1:1 coaching and rewards.
  • Basic and supplemental life insurance.
  • Accident, hospital indemnity, and critical illness insurance.
  • Paid time off.
  • Paid parental leave.
  • Short- and long-term disability.
  • 9 paid holidays.