Manager, Process Engineering

Role Summary

The Manager, Process Engineering leads cross-functional programs spanning equipment customization to large bio-process scale-up. Responsibilities include evaluating new manufacturing systems and process changes to improve yield, increase capacity, and reduce production costs. The role builds and leads a team to design systems, execute experimental protocols, collect and evaluate data, and summarize findings in reports, while developing and executing validations. A hands-on, problem-solving, team-oriented individual who communicates across departments and can own projects from concept through manufacturing, with up to 20% travel and off-hours support during startup of new facilities.

Responsibilities

• Manage projects of diverse scope from small equipment customization to large bio-process scale-up.
• Evaluate state-of-the-art manufacturing systems and process changes to improve yield, capacity, and overall production costs.
• Build and lead a team to design systems and execute experimental protocols, including data collection and analysis, with written reporting.
• Develop and execute validations.
• Collaborate across functional departments to communicate findings and manage stakeholder expectations.
• Maintain a hands-on approach to problem solving and oversee project plans to meet timelines, budgets, and quality standards.
• Travel up to 20% for vendor qualifications, design reviews, and factory acceptance testing; accommodate off-hours work and weekends for critical schedules during startup.

Qualifications

• Required: B.S. in Chemical Engineering or Biomedical Engineering or related field
• Required: Management of complex cross-functional programs
• Required: Knowledge of aseptic processing methods
• Required: 7–10 years of industry-related experience with at least 2–3 years of experience managing an engineering team
• Required: Aseptic technique
• Required: AutoCAD proficiency
• Required: Understanding of industry process systems under GMP
• Required: Electromechanical system debugging
• Required: Proficiency in MS Office (Word, Excel, PowerPoint)
• Required: Ability to perform functions in a cleanroom environment while fully gowned for up to 6 hours per day
• Required: Organized and detail oriented
• Required: Strong process and mechanical aptitude with a hands-on approach
• Required: Ability to mentor, train, and lead an engineering team
• Required: Excellent communication skills to collaborate with cross-functional teams and manage stakeholder expectations
• Required: Strong planning, execution, and project oversight to ensure timelines, budgets, and quality standards

Skills

• Cross-functional program management
• Aseptic processing and GMP knowledge
• System design and validation planning
• Data collection, analysis, and technical reporting
• Team leadership and mentoring
• Problem-solving and hands-on engineering approach

Education

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

Additional Requirements

• Up to 20% travel for vendor qualifications, design reviews, and factory acceptance testing
• Ability to work in a cleanroom environment and tolerate industrial settings as needed