Senior Process Engineer

Job Title: Senior Process Engineer

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

MSAT is a partner of biologics manufacturing operations and is the custodian of manufacturing processes.  Technical Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

• Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

• Anticipate, respond to, and permanently resolve issues that arise during production.

• Lead the creation and use of digital process data analytic systems.

• Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

• 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, ultra-filtration/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 various functions such as Engineering, Manufacturing, and Quality Departments to coordinate the progression of projects.

About You

Basic Qualifications

• Bachelor’s degree in engineering or science with 9 years of experience OR

• Master’s degree in engineering or science with 7 years of experience OR

• PhD in engineering or science with 5 years of experience.

Preferred Qualifications

• Experience in biotechnology or the pharmaceutical industry

• Experience in extractable and leachable risk assessments and calculations

• Experience in purification (chromatography, UFDF, filtration)

• Experience with root cause analysis and/or risk assessment

• Knowledge of DeltaV automation

• Experience working with statistical analysis software

• Experience providing solutions for difficult technical issues

• Strong technical writing and communication skills

• Experience with project leadership

• Experience communicating with cross functional teams

Special Working Conditions

• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whe