Manager, Process Engineering

Role Summary

Manager, Process Engineering. Responsible for managing projects ranging from small equipment customization to large bio-process scale-up. Lead a team to design systems and execute experimental protocols, develop and execute validations, and communicate findings across functional departments. Travel up to 20% for vendor qualifications, design reviews, and factory acceptance testing; some off-hours and weekend work may be required to support startup and validation schedules.

Responsibilities

• Manage complex cross-functional programs and coordinate with multiple stakeholders
• Evaluate new manufacturing systems and process changes to improve yield, capacity, and reduce production costs
• Build and lead a team to design systems and execute experimental protocols, collect and evaluate data, and summarize findings in written reports
• Develop and execute validations
• Communicate across functional departments and mentor/train engineering staff
• Ensure adherence to timelines, budgets, and quality standards

Qualifications

• Required: B.S. in Chemical Engineering, Biomedical Engineering, or related field
• Required: 7‚Äì10 years of industry experience with 2‚Äì3 years of engineering team management
• Required: Knowledge of aseptic processing methods and aseptic technique
• Required: Understanding of industry process systems under GMP
• Required: AutoCAD proficiency; Electromechanical system debugging
• Required: Proficiency in MS Office (Word, Excel, PowerPoint)
• Required: Ability to work in a cleanroom environment, fully gowned for up to 6 hours per day
• Required: Strong planning, organizational, and communication skills; hands-on problem solving; ability to mentor and lead an engineering team
• Preferred: Experience mentoring and leading cross-functional teams; strong cross-functional collaboration

Skills

• Process development and scale-up
• Project management and cross-functional leadership
• Laboratory and manufacturing validation execution
• Data collection, analysis, and reporting
• Clear written and verbal communication

Education

• B.S. in Chemical Engineering, Biomedical Engineering, or related field

Additional Requirements

• Up to 20% travel required for vendor qualifications, design reviews, and factory acceptance testing