Posted in General Business 10 days ago.
Location: San Diego, California
We are looking for driven, talented Process Engineers to join New Product Introduction team in the Process Development and Transfer (PDT) group. The PDT group works as an integral part of our Consumables Development and Manufacturing process and is tasked with developing and deploying consumables manufacturing processes of New Products within our production environments. The individual will provide technical leadership to new product introduction, and production process development. Additionally, s/he will partner cross-functionally with R & D, Quality, Production, Supply Chain, and other engineering groups to develop, transfer and sustain manufacturing processes for new products.
Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomes.
Define technical requirements for manufacturing processes and new production equipment
Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
Design, develop and source production equipment from vendors, work cross functionally with EHS and Facilities to establish safe production processes to enable manufacturing of consumable products
Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals
Analyze process test results, issue reports and make technical recommendations to improve product and process quality
Represent Operations needs on development teams for effective transfer of products into manufacturing
Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturing
Ensure successful transfer of knowledge into manufacturing and the sustaining support teams.
Work experience in the medical device, biotech, pharmaceutical, industries is desired
Experience with reagent formulation, filling, labeling and packaging technologies preferred
Experience and understanding of complex automated manufacturing systems, tools and components (electrical and pneumatic control, sensors, metrology systems, PLCs) is desired
Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
Effective communication skills both verbal and written, analytical and organizational skills to manage different priorities
Experience with Statistics, Statistical Process Control and DOE techniques is a plus
Experience with product development processes, design transfer and process and equipment validation
High level problem solving, and reasoning skills required
Experience with high volume production in a high tech, high volume consumables industry is a plus
High level computer skills are required. Intermediate level programming knowledge is a plus
Experience with product development processes and project management is a plus
Demonstrated ability to accomplish goals while working across departments is required
Ability to work independently and collaborate
Education and Experience:
B.S./M.S. in Mechanical, Chemical Engineering, Bioengineering, Manufacturing Engineering, or Material Science with 2-4 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation
PhD in Mechanical, Chemical Engineering, Bioengineering, Biomedical Engineering, Manufacturing Engineering, Materials Science or Physical Chemistry Relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation is a plus