Process Engineer 1

The Process Engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space. Assesses facility fit, equipment needs, and manufacturing capabilities for potential new products.Determines process needs/requirements for processes moving from Development to GMP.Creates detailed process overviews and flow diagrams.Identifies and orders equipment for use in GMP manufacturing.Establishes manufacturing equipment specifications.Generates, reviews, and approves engineering, manufacturing, and quality procedures necessary to support equipment qualification and operation of equipment in GMP manufacturing (procedures and product-specific recipes).Initiates, reviews/approves equipment change request.Develops and/or implements systems improvement projects and support.Maintenance and Manufacturing groups in resolving technical and engineering issues.Supports Manufacturing and Maintenance groups in troubleshooting manufacturing equipment.Supports Validation in Equipment and Process Validation activities per GMP regulation.Facilitates training for individuals involved in the operation and maintenance of processes and equipment introduced to the manufacturing department. Who You Are Minimum Qualifications: Bachelors Degree in Engineering (eg. Electrical, Mechanical, or Chemical) or other Life Science discipline. 2 + years' experience in GMP Operations. Preferred qualifications: Comprehensive technical knowledge and understanding of GMP manufacturing equipment and biologics production processes.Experience with AKTA and Mobius systems is highly preferred.Excellent attention to detail and ability to effectively manage multiple projects.Effective communication and engagement skills (verbal, written, listening) - ability to work with internal departments and customers.Able to build a culture of trust and business driven innovation. Work with internal organizations to solve on-going issues within the team.Communicate and lend guidance on day-to-day workflow and overcoming challenges related to completing projects.RSREMD