Senior Process Engineer

Role Summary

Senior Process Engineer in Framingham, MA, within MSAT for biologics manufacturing operations. Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement. Lead the creation and use of digital process data analytic systems and partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Responsibilities

• Act as subject matter expert on extractable leachable compounds for a facility using single-use components.
• Demonstrates solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways, focusing on downstream operations including chromatography, ultrafiltration/diafiltration, and nanofiltration.
• Maintains and demonstrates knowledge of state-of-the-art principles and theories in their area of responsibility.
• Leads small technical project teams.
• Reviews manufacturing processes and/or development and production data.
• Designs and conducts necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments.
• Provides technical guidance and trains less experienced staff.
• Interacts with colleagues from Engineering, Manufacturing, and Quality Departments to coordinate the progression of projects.

Qualifications

• Required: Bachelor’s degree in engineering or science with 9 years of experience
• Required: Master’s degree in engineering or science with 7 years of experience
• Required: PhD in engineering or science with 5 years of experience
• Preferred: Experience in biotechnology or the pharmaceutical industry
• Preferred: Experience in extractable and leachable risk assessments and calculations
• Preferred: Experience in purification (chromatography, UFDF, filtration)
• Preferred: Experience with root cause analysis and/or risk assessment
• Preferred: Knowledge of DeltaV automation
• Preferred: Experience working with statistical analysis software
• Preferred: Experience providing solutions for difficult technical issues
• Preferred: Strong technical writing and communication skills
• Preferred: Experience with project leadership
• Preferred: Experience communicating with cross functional teams

Education

• Bachelor’s degree in engineering or science (with 9 years of experience)
• Master’s degree in engineering or science (with 7 years of experience)
• PhD in engineering or science (with 5 years of experience)

Additional Requirements

• Travel requirement
• Ability to lift weight
• Ability to gown and gain entry to manufacturing areas
• Support manufacturing operations on an "on call" 24/7 basis