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Sr Process Engineer Reagent Manufacturing

Location
San Diego, CA

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Job Description:
Position Summary:
We are looking for driven, talented Process 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 increasing quality and yield within our high-volume and high-mix production environments. These individuals provide technical and operations 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, as well as sustain and improve processes for existing products.
Responsibilities:
Train in Reagent Manufacturing to grasp full understanding of area’s operational requirements and needs. Will gain ability to fully sustain Reagent Manufacturing while networking with cross-departmental support and process improvement teams in Quality, Validation, Equipment Engineering, and Manufacturing.
Work cross functionally with R&D, Manufacturing, Regulatory, and Quality 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 and customer complaints related to yield, quality, and throughput. Implement the appropriate robust containments and corrective actions on identification of root cause.
Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues, reduce costs, and drive implementation of solutions in a production environment to meet production goals.
Analyze process test results, issue reports, and make technical recommendations.
Requirements:
Work experience in the biotech, diagnostic, pharmaceutical, or medical device industry is required.
High-level problem solving and reasoning skills required.
Experience in production support, process development and project management skills is required.
Good interdepartmental communication skills and documentation skills are required.
Demonstrated ability to accomplish goals while working across departments is required.
High level computer skills are required. Intermediate level programming knowledge is strongly desired.  Experience with large data sets a plus.
Experience working in an ISO13485 or FDA certified environment is desirable.
Experience expanding production capacity and automating processes is desired.
Experience with high volume production in a high-tech consumables industry is highly desired.
Experience with liquid handling and filling technologies preferred.
Experience with fluorescence imaging technologies preferred.
Experience with chemical processes (preferably organic) preferred.
Experience applying statistics, Statistical Process Control, and DOE techniques is a plus.
Education:
B.S./M.S./PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics or MS/PhD in Materials Science or Physical Chemistry, with at least 4 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
Lead teams in documenting, validating and implementing change. Define and drive execution of validation plans and protocols.
Define technical requirements and write procedures for production to process product.
Transfer technology, manufacturing and QC processes and products from Development into a regulated manufacturing environment. Represent Operations needs on those Development teams.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at ****. To learn more, visit: ****Apply Now
Responsibilities:
Train in Reagent Manufacturing to grasp full understanding of area’s operational requirements and needs. Will gain ability to fully sustain Reagent Manufacturing while networking with cross-departmental support and process improvement teams in Quality, Validation, Equipment Engineering, and Manufacturing.
Work cross functionally with R&D, Manufacturing, Regulatory, and Quality 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 and customer complaints related to yield, quality, and throughput. Implement the appropriate robust containments and corrective actions on identification of root cause.
Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues, reduce costs, and drive implementation of solutions in a production environment to meet production goals.
Analyze process test results, issue reports, and make technical recommendations.
Requirements:
Work experience in the biotech, diagnostic, pharmaceutical, or medical device industry is required.
High-level problem solving and reasoning skills required.
Experience in production support, process development and project management skills is required.
Good interdepartmental communication skills and documentation skills are required.
Demonstrated ability to accomplish goals while working across departments is required.
High level computer skills are required. Intermediate level programming knowledge is strongly desired.  Experience with large data sets a plus.
Experience working in an ISO13485 or FDA certified environment is desirable.
Experience expanding production capacity and automating processes is desired.
Experience with high volume production in a high-tech consumables industry is highly desired.
Experience with liquid handling and filling technologies preferred.
Experience with fluorescence imaging technologies preferred.
Experience with chemical processes (preferably organic) preferred.
Experience applying statistics, Statistical Process Control, and DOE techniques is a plus.
Education: B.S./M.S./PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics or MS/PhD in Materials Science or Physical Chemistry, with at least 4 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
Lead teams in documenting, validating and implementing change. Define and drive execution of validation plans and protocols.
Define technical requirements and write procedures for production to process product.
Transfer technology, manufacturing and QC processes and products from Development into a regulated manufacturing environment. Represent Operations needs on those Development teams.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at ****. To learn more, visit: **** >
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