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 chromatography, ATF XCell 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
- Drive tech transfer and dual site manufacturing opportunities in support of high growth / demand
- 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 Chromatography & Filtration
- Contribute to the process design for new products during the development phase
- Develop standardized documentation including SOP’s, training, validation of equipment, and reports
- Provide accurate and timely reporting to internal and external stakeholders in support 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
- Mentor and coach team members in all areas of expertise
Qualifications
- Engineering degree or equivalent required
- 5-10 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 laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges / sensors) and operation of process-scale manufacturing equipment
- Experiences with any / all of the following processes are desired : Process and Equipment Validation / Qualification, Chromatography scale up and Packing, Technology transfer between manufacturing sites, Data analysis
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