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Process Development Engineer

Employer
Katalyst Healthcares & Life Sciences
Location
Conimicut, RI
Closing date
Jun 11, 2024

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Responsibilities:

Participates in process sustaining, definition and improvement, design, development, and quality test activities under general instruction.

Troubleshoots production line issues related to yield, quality, and throughput.

Participates in establishing operating equipment specifications and improvements

Constructs and executes controlled experiments to address yield and quality issues and drives implementation of solutions in a production environment to meet production goals

Conducts controlled process optimization experiments for release into production environment

Works cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products

Defines technical requirements and procedures for manufacturing to process product

Organizes and participates in required execution of validation protocols and drive the release of the corresponding report

Participate in process design, development, definition, and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomes.

Requirement:

Technology transfer and continuous improvement experience

Ability to write/report Protocols, reports, SOP'S, work instructions, etc.

Design 3D modeling using CAD, create drawings and partner with vendors for prototype/production

Support Deviation Management

Understanding of cGxP principles and practices

ISO 13485, 14971

Experience in API final form definition

Proven leadership experience (projects, people, labs)

Experience related to upstream and/or downstream process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP)

MS in Biotechnology, or related field with at least 4 years of bio pharmaceutical process development and manufacturing experience

Associate degree/Certificate/Diploma in laboratory science

Strong technical knowledge and hands on experience with biological manufacturing

Looking for someone with a background in Chemistry scale up or chemistry processes from a regulated Medical Device environment.

Polymer Science background

Experience synthesizing polymers and understands the polymerization process.

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