Senior Process Engineer Microarrays

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
San Diego, CA
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

Position Summary:


We are looking for driven, talented Process and Product Engineers to join our growing Life Cycle Management (LCM) group. The LCM group works as an integral part of our Consumables Manufacturing process and is tasked with introducing new products to manufacturing, and increasing quality and yield within our high volume production environments.
We are growing at a rapid rate and hiring experienced engineers at all levels (II, Sr. and Staff) to support Microarrays. These individuals will provide technical leadership to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.

Responsibilities:


• Participate in production process definition and improvement, design, development and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomes.
• Troubleshoot production line 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 in a production environment to meet production goals.
• Analyze process test results, issue reports and make technical recommendations.
• Work with our Singapore team to transfer best practices between sites.
• Lead teams in implementing change.
• Design, develop, test, and implement changes to increase throughput and yield, and/or reduce costs.
• Work cross functionally with R&D, Manufacturing, Regulatory and Quality to develop processes for new products and improve processes of existing products.
• Represent Operations needs on development teams.  With cross-functional team execute on tech transfer activities with compliance to regulatory and quality system requirements. 
• Define technical requirements and write procedures for Production to process product.
• Define and drive execution of validation plans and protocols.
• Work on teams to develop and transfer new processes/products to production and enhance their robustness. 
 
Requirements:


• Work experience in the biotech, diagnostic, pharmaceutical, or medical device industry is desired.
• At least 5 years of relevant production experience required.
• Experience expanding production capacity and automating processes required.
• Experience with Critical/Key Parameter Management is a plus.
• High level problem solving and reasoning skills required.
• Experience with high volume production in a high tech, high volume consumables industry is highly desired.
• Experience with chemical, biochemical, or surface functionalization processes highly preferred.
• Experience applying statistics, Statistical Process Control and DOE techniques is a plus.
• High level computer skills are required. Intermediate level programming knowledge is strongly desired.  Experience with large data sets a plus.
• Experience with product development processes and project management is desired.
• Good interdepartmental communication skills and documentation skills are required.
• Demonstrated ability to accomplish goals while working across departments is required.

Education:


• B.S./M.S./ PhD in Engineering, Bioengineering, Biotechnical Engineering, Industrial or Manufacturing Engineering,  or MS/PhD in Materials Science or Physical Chemistry, with at least 5 years of relevant experience in production support and/or process definition and development, design, scale-up, improvement and validation.

7133BR

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