Overview

Overview

We are seeking motivated and experienced process engineer who will focus on multiproduct manufacturing support, project execution, validation, and tech transfer. The position is based in Massachusetts and will be focused on Process support & development for multiple product lines within the field of bioprocessing. 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 the key interface between manufacturing, quality and R&D. Hands-on mechanical aptitude and an exceptional problem-solving ability are important.

Responsibilities

Responsibilities

• Provide technical support for multiple bioprocessing manufacturing processes
• Drive tech transfer, expansion, and dual site manufacturing opportunities in support of high growth/demand
• Perform commissioning and qualification activities to support continuous improvement
• Research and implement process improvements to support best in class manufacturing
• 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
• Mentor and coach team members in all areas of expertise
• Provide accurate and timely project reporting to internal and external stakeholders
• Develop and own Process Improvement projects.

Qualifications

Qualifications

Engineering degree or equivalent required

• 0-3 years of engineering experience in a manufacturing or development environment
• Ability to execute projects within time and budget constraints
• Excellent presentation, verbal, and written communication skills
• Experience with the operation of manufacturing equipment (testing, assembly, fixturing, robotics, casting, pneumatic presses) and operation of process-scale manufacturing equipment
• Effective at change management

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

• Process and Equipment Validation/Qualification
• Technology transfer
• Statistical Process Control
• Tangential Flow Filtration
• Chromatography
• Proteins Manufacturing
• Data analysis
• Automation
• Ability to think outside the box and solve complex problems