|The Bioprocess Engineer is responsible for developing and optimizing Repligen's OPUS line of pre-packed chromatography columns. Critical responsibilities will include the design and sourcing of column components, and the procurement and validation of manufacturing and testing equipment.
The successful candidate must have experience in packing and operation of chromatography columns, and will bring resourcefulness, creative thinking and practical ideas to the project. The Engineer will manage numerous vendors, and will provide a bridge between Manufacturing, Quality and Marketing departments for facilitation of new product implementation and customer support.
Duties and responsibilities:
Implement Manufacturing process transfer and process validation for newly developed product lines
Lead the development and implementation of custom processes in compliance with customer needs and ISO9001 requirements
Cross-train (or, as appropriate, hire and train new) operators on manufacturing processes
Establish Raw material procurement and shipping systems for new product lines
Establish, implement and validate process transfer and product release criteria for new product lines
Improve and optimize commercial scale manufacturing processes for new products to increase efficiency and lower production costs. Provide technical resources as needed to
support and improve ongoing manufacturing
Coordinate integration of new product lines into Repligen quality system by drafting technical aspects of process documents and procedures in collaboration with QA and QC.
Assure ISO9001 compliance of all new Repligen products and processes
As required, provide technical support and field service to Repligen customers on existing and new products and services
Provide general customer support for marketing and sales efforts, including technical demonstrations, assessment of customer requirements, process specific applications and problem solving
Identify and promote improvement opportunities for existing Repligen products and Manufacturing processes
Bachelor's degree in an engineering (biomedical, mechanical, chemical, materials etc.) or a related field
Minimum two years of industry experience in bioprocessing environment
Detailed knowledge of chromatography systems is essential
Working knowledge of basic principles of biology, chemistry and physics with the ability to synthesize information and to understand and solve technical problems in bioprocessing applications
Excellent communication skills with the ability to interact effectively and cooperatively with customers and industry experts
State or Province