Overview

We are seeking motivated and experienced process engineer who will focus on multiproduct manufacturing support, project execution and tech transfer. The position is based in Marlborough, MA and will be focused on Process support & development for filtration products. This individual will work closely with Manufacturing and R&D to improve current and new products. The successful candidate will play a key role in ensuring that the department's production and quality goals are met. The applicant will be a key interface between manufacturing, quality and R&D. 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
• Develop and own commissioning and qualification programs to support continuous improvement, expansion and validation activities
• Perform research and implementation of process improvements to support best in class manufacturing in the areas of Filtration & Support Systems
• Contribute to the process design for new products during the development phase
• Develop standardized documentation including SOP’s, training, validation of equipment, and reports
• Support execution of Repligen’s global capital project portfolio
• Identify and resolve process and quality related problems for assigned manufacturing processes
• 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+ years of engineering experience in a manufacturing or development environment
• Demonstrated track record of successful project execution
• Excellent presentation, verbal, and written communication skills
• Effective at change management

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

• Process and Equipment Validation/Qualification
• Statistical Process Control and Data Analysis
• Tangential Flow Filtration
• Automation
• Ability to think outside the box