Manager, Process Engineering

Overview

Manager, Process Engineering role bridge, MA. The position focuses on managing projects that span from small equipment customization to large bio-process scale-up. Projects will evaluate new manufacturing systems and process changes to improve product yield, increase capacity and reduce production costs. The role requires building and leading a team to design systems, execute experimental protocols, collect and evaluate data, and summarize findings in written reports.

It includes developing and executing validations and may require up to 20% travel for vendor qualifications, design reviews and factory acceptance testing. Off hours work and weekends may be needed to accommodate critical production and validation schedules during start-up of new processing facilities.

The position is responsible for managing projects of a diverse scope ranging from small equipment customization to large bio-process scale-up. Responsibilities include evaluating state-of-the-art 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 and execute experimental protocols, collect and evaluate data, and summarize findings in written reports.

You will develop and execute validations, work with cross-functional teams, and communicate across departments. You should be an independent self-starter who can take ownership from concept through manufacturing. The role requires occasional travel and flexibility around production schedules.

• B.S. Chemical Engineering or Biomedical Engineering or related field
• Management of complex cross-functional programs
• Knowledge of aseptic processing methods
• 7–10 years of industry-related experience with at least 2–3 years managing an engineering team
• Aseptic technique
• AutoCAD proficiency
• Understanding of industry process systems under GMP
• Electromechanical system debugging
• Proficiency in MS Office:
  Word, Excel, Power Point
• 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 hands-on approach
• Ability to mentor, train and lead an engineering team
• Excellent communication skills to collaborate with cross-functional teams and manage stakeholder expectations
• Strong abilities in planning, executing and overseeing projects, ensuring timelines, budgets and quality standards

• 401k with generous employer match and immediate vesting
• Comprehensive medical, dental and vision coverage from day one
• Flexible Spending Account or Health Savings Account
• Company-paid insurances including Short Term, Long Term and Life insurance, with voluntary options
• Paid maternity and parental leave
• Adoption benefits
• Education assistance policy ($5,000 per year)
• Wellness program with mental health resources, mindfulness, stress reduction, on-site flu shots, and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days and company holidays
• Free parking with electric charging station (Canton and La Jolla)
• Discounts at select vendors

Equal Opportunity Employer. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes.