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 Waltham, MA and will be focused on process support & development for OPUS, ELISA and Affinity Ligand product lines. 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

• Serve as a Subject Matter Expert (SME) for multiple bioprocessing manufacturing processes

• Implement new product processes in Manufacturing during the transfer from Product Development  

• Contribute to the process design for new products during the development phase

• Complete IQ/OQ/PQ’s on equipment and processes as needed

• Develop standardized documentation including SOP’s, training, validation of equipment, and reports

• Provide accurate and timely project reporting to internal and external stakeholders

• Identify and resolve process and quality related problems for manufacturing processes

• Optimize current processes through data and identify emerging technologies for future implementation

• Implementation of corrective actions to solve problems based on root cause analysis

• Develop and own Process Improvement projects.

Qualifications

• Engineering degree or equivalent required

• 5-7+ years of engineering experience in a manufacturing or product development environment

• Demonstrated track record of successful project execution

• Excellent presentation, verbal, and written communication skills

• Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment.

• CAD and FEA experience using Solidworks to create drawings and assemblies

• Experience working in a regulated industry, familiar with ISO, GMP.

• Good computer skills such as Microsoft Excel, Word, Project, and an ability to learn SAP.