Overview

We are seeking motivated and experienced process engineer who will focus on multiproduct manufacturing support, project execution and tech transfer of filtration products, based in Marlborough, MA. This individual will work closely with Manufacturing, Quality, and R&D to improve current and new products.  Hands-on mechanical aptitude and a strong problem-solving ability are important.

Responsibilities

• Serve as a Subject Matter Expert (SME) for multiple bioprocessing manufacturing processes
• Identify and resolve process and quality related problems for assigned manufacturing processes
• Develop and own commissioning and qualification programs to support continuous improvement, expansion and validation activities
• Contribute to the process design for new products during the development phase
• Develop standardized documentation including SOP’s, training, validation of equipment, and reports
• Optimize current processes and identify emerging technologies for future implementation
• Implementation of corrective actions to solve problems based on root cause analysis
• Drive the adoption of statistical process control and automated systems
• Provide accurate and timely project reporting to internal and external stakeholders
• Develop and own Process Improvement projects.

Qualifications

Engineering degree or equivalent required.  2-5+ years of engineering experience in a manufacturing or development environment

• Demonstrated track record of successful project execution
• Excellent presentation, verbal, and written communication skills
• Experience with the operation of manufacturing equipment (testing, assembly, fixturing, robotics, casting, pneumatic presses)
• Effective at change management and Quality systems
• Experience with filtration products preferred

 Experiences with any/all of the following processes are desired:

• Process and Equipment Validation/Qualification
• Technology transfer between manufacturing sites
• Statistical Process Control
• Tangential Flow Filtration and Hollow Fiber Filtration
• Data analysis
• Automation
• Facilities engineering
• Ability to think outside the box
• Proficiency with standard business software is required (Office 365, Teams, etc.).
• Preferred experience with SolidWorks, Ignition, SAP, Minitab, Smartsheet