Manager, Process Engineering

Role Summary

Manager, Process Engineering will lead cross-functional programs ranging from equipment customization to large-scale bio-process scale-up. You will evaluate new manufacturing systems and process changes to improve yield, increase capacity, and reduce overall production costs. You will build and lead a team to design systems, execute experimental protocols, collect and evaluate data, and summarize findings in written reports, and you will develop and execute validations. You are a hands-on, independent self-starter who can communicate across functional departments and take ownership from concept through manufacturing; travel up to 20% may be required for vendor qualifications, design reviews, and factory acceptance testing.

Responsibilities

• Manage projects of a diverse scope ranging from small equipment customization to large bio-process scale-up; evaluate new state-of-the-art manufacturing systems and process changes that will improve product yield, increase capacity and/or reduce overall production costs.
• Build and lead a team to design systems and execute experimental protocols including collecting and evaluating data and summarizing findings in written reports.
• Develop and execute validations.
• Maintain a hands-on approach to problem solving and work as a highly motivated, team-oriented individual that can communicate across functional departments.
• Independent self-starter who can work with minimal direction and take ownership of a job from concept through manufacturing.
• Travel up to 20% for vendor qualifications, design reviews and factory acceptance testing.

Qualifications

• B.S. Chemical Engineering or Biomedical Engineering or related field
• Management of complex cross-functional programs
• Knowledge of Aseptic Processing Methods
• 7 - 10 yrs of industry related experience with at least 2 - 3 years of experience of managing an engineering team
• Aseptic Technique
• AutoCAD proficiency
• Understanding of industry process systems under GMP
• Electromechanical system debugging.
• Proficiency in MS Office: Word, Excel, PowerPoint
• Ability to perform functions in a cleanroom environment while fully gowned for up to 6 hours per day (with breaks).
• Organized and detail oriented
• Strong process and mechanical aptitude with an enthusiastic hands-on approach.
• The ability to mentor, train and lead an engineering team
• Excellent Communication skills are needed to effectively collaborate with cross-functional teams, manager stakeholder expectations
• Strong abilities in planning, executing and overseeing projects, ensuring adherence to timelines, budgets and quality standards

Education

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

Additional Requirements

• Off-hours work and weekends as needed to accommodate critical production and validation schedules during start-up of new processing facilities.