Repligen Corporation

Process Engineer – TFF and Chromatography Systems

Job Locations US-MA-Marlborough
ID
2022-3687
Category
Research & Development
Type
Full-Time

Overview

Repligen is a bioprocessing-focused life sciences company bringing over 30 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs.

Responsibilities

Essential Duties and Responsibilities:

 

The process engineer will report directly to Director – Automation and will be primarily responsible for the support of Tangential Flow Filtration – TFF and Chromatography products from a process perspective.  This role will work with automation, product management, and engineering to determine components, pumps, valves, flow sensors, tubing diameters, etc. best suited for the application and flow paths. Process engineer will interact with Product Management and application SMEs to understand the process, automation requirements and define functional requirements specification document (FRS). This role will work with automation engineers to develop the software to meet Product requirements. Upon development, Process engineer will be responsible for verification / validation to ensure the system functions according to the requirements. They will also have responsibility for collaborating with automation engineers, creation and maintenance of documentation in accordance with ISO requirements. The successful candidate will actively work with all levels of R&D and manufacturing personnel, product development, and planning and training of manufacturing personnel.

 

Work with Product Development, Product Management, and Planning as a technical engineering lead on the TFF and Chromatography product lines. Manage the implementation of new product processes into Manufacturing during the transfer from Product Development.

 

Develop and release component specifications and bill of materials through the change order process.

Become the expert on current and new processes.

Work closely with Product Development and Quality Management focused on improving manufacturing processes.

Identify and resolve process and quality related problems for assigned processes.

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

Coach, develop, and mentor junior engineers.

Qualifications

Education and/or Work Experience Requirements:

 

·        BS Chemical Engineering degree or related engineering degree

·        3-5 years of engineering experience in a biological product manufacturing or equipment supplier to biotech companies

·        Have knowledge of process instruments and automation

·        Understand documentation requirements for the GMP manufacturing process

·        Demonstrated track record of successful project leadership and execution

·        Excellent presentation, verbal and written communication skills

·        Ability to lead in a cross functional team environment

·        Work with suppliers to develop functional test fixtures

·        Knowledge of electromechanical equipment and controls

·        Able to work with outside vendors and manage their assigned work

Self-starter with plenty of drive.

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