Job Description:
As a Sr. Staff Validation Engineer for Manufacturing Software/System and Process Validation at Illumina, you will work in a dynamic, team-oriented environment and play a significant role in implementation and validation of software/systems used in the manufacture of leading edge research and clinical diagnostics instruments for genomic analysis. You will be part of a team of Validation Engineers who establish and maintain the validated state of various instrument manufacturing operations within your site and support technology transfer to other sites as needed. You will participate in the launch and validation of new software and instrumentation and will also provide support to manufacturing to satisfy the quality and process/software validation requirements for existing products in a rapid growth environment. All About You: Responsibilities: Site Validation/Quality Management: -Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits. -Assess new and existing processes against cGMP and ISO 13485 requirements for equipment, software, test method, and process validation and help determine when re-validation is required. -Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC 62304. -Manage individual validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports. -Work with cross-functional teams to garner technical support and schedule resources (e.g., people, instruments) to execute validation protocols. -Manage and/or assist with management of overall validation schedule for the manufacturing site and report status/progress to site management teams. -Support maintenance of validated state under Site Validation Master Plan and update Site Validation Master Plan as needed. -Uphold expectations for quality performance, continuous improvement, quality systems, process controls, and infrastructure for critical sustaining parts and new products. -Collaborate with peers and stakeholders to identify opportunities for process improvement. -Document procedures, work instructions, checklists, and templates for system and process validation and returned material assessments. -Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites. -Assist with documentation of nonconformances and process deviations. -Support complaint investigations and implementation of CAPAs, as needed. -Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures. Software/System Implementation and Validation: -Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software. -Assist with development and review of system/software requirements to ensure testability. -Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts. -Perform equipment IQ/OQ/PQ, gauge R&R (repeatability and reproducibility), test method validation, and spreadsheet validation. -Ensure that testers are trained on Good Documentation Practices and procedures for protocol execution and deviation resolution. -Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports. -Assist with documentation and resolution of deviances that occur during validation. -Assist with determination of root cause, impact, and resolution of problems impacting production. -Partner cross-functionally with R & D, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products. -May lead cross-functional teams to address software/system issues. -Advanced planning for and management of hardware/software changes. Configuration and Supplier Quality Management: -Assist in managing introduction of hardware/software configuration changes into manufacturing. -Assist with identification of critical parts and end-of-life/ replacement parts and the associated planning, re-validation, and configuration management, as required. -Trigger, coordinate, and/or support supplier audits and follow-up. -Assist in determining outgoing quality checks for suppliers and incoming quality checks for receipt of materials/subsystems. -Assist with/coordinate testing of first article configuration. Requirements: -Experience in the medical device/IVD or biotech/pharmaceutical industry in software/system validation, equipment/test method/process validation, quality management, process controls, and continuous improvement methods. -5-10 years in manufacturing, quality assurance, and/or software engineering/validation in an FDA-regulated environment. -Knowledge and working application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, GAMP 5, and 21 CFR Part 11/820. -Knowledge and working application of validation principles and guidelines and industry best practice. -Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment. -Demonstrated analytical problem solving and interpersonal skills. -Ability to work independently or in a team setting. -Ability to communicate effectively across functions and organizational levels. -Ability to successfully prioritize and manage multiple projects across several product lines. -Excellent verbal and written communication/documentation skills. -Strong attention to detail. Preferred Attributes: -ASQ accreditation, Lean Six Sigma, and/or PMP certification. -Experience performing FMEA and Risk Analysis. -Experience with bioinformatics, statistics, Statistical Process Control, and/or Design of Experiments techniques. -Solid understanding of manufacturing processes in high-tech medical device manufacturing. -Experience with Microsoft Office, Microsoft Project, Visual Studio, SAP/ERP, and Manufacturing Execution Systems. -Ability to discuss technical topics with non-technical people. Education: Requires a Bachelors, Masters, or Ph.D./Pharm.D. degree in engineering, science, medicine, or bioinformatics (or equivalent combination of education and experience) and a minimum of 10 years of related experience. EOE / Minorities / Females / Veterans / Disabled
Additional Info:
All About Us: Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives. Headquartered in San Diego, California, Illumina (NASDAQ: ILMN), is a leading developer, manufacturer, and marketer of next generation life science tools and integrated systems for large-scale analysis of genetic variation and biological function. [Click Here to Access the Original Job Post]
As a Sr. Staff Validation Engineer for Manufacturing Software/System and Process Validation at Illumina, you will work in a dynamic, team-oriented environment and play a significant role in implementation and validation of software/systems used in the manufacture of leading edge research and clinical diagnostics instruments for genomic analysis. You will be part of a team of Validation Engineers who establish and maintain the validated state of various instrument manufacturing operations within your site and support technology transfer to other sites as needed. You will participate in the launch and validation of new software and instrumentation and will also provide support to manufacturing to satisfy the quality and process/software validation requirements for existing products in a rapid growth environment. All About You: Responsibilities: Site Validation/Quality Management: -Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits. -Assess new and existing processes against cGMP and ISO 13485 requirements for equipment, software, test method, and process validation and help determine when re-validation is required. -Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC 62304. -Manage individual validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports. -Work with cross-functional teams to garner technical support and schedule resources (e.g., people, instruments) to execute validation protocols. -Manage and/or assist with management of overall validation schedule for the manufacturing site and report status/progress to site management teams. -Support maintenance of validated state under Site Validation Master Plan and update Site Validation Master Plan as needed. -Uphold expectations for quality performance, continuous improvement, quality systems, process controls, and infrastructure for critical sustaining parts and new products. -Collaborate with peers and stakeholders to identify opportunities for process improvement. -Document procedures, work instructions, checklists, and templates for system and process validation and returned material assessments. -Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites. -Assist with documentation of nonconformances and process deviations. -Support complaint investigations and implementation of CAPAs, as needed. -Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures. Software/System Implementation and Validation: -Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software. -Assist with development and review of system/software requirements to ensure testability. -Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts. -Perform equipment IQ/OQ/PQ, gauge R&R (repeatability and reproducibility), test method validation, and spreadsheet validation. -Ensure that testers are trained on Good Documentation Practices and procedures for protocol execution and deviation resolution. -Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports. -Assist with documentation and resolution of deviances that occur during validation. -Assist with determination of root cause, impact, and resolution of problems impacting production. -Partner cross-functionally with R & D, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products. -May lead cross-functional teams to address software/system issues. -Advanced planning for and management of hardware/software changes. Configuration and Supplier Quality Management: -Assist in managing introduction of hardware/software configuration changes into manufacturing. -Assist with identification of critical parts and end-of-life/ replacement parts and the associated planning, re-validation, and configuration management, as required. -Trigger, coordinate, and/or support supplier audits and follow-up. -Assist in determining outgoing quality checks for suppliers and incoming quality checks for receipt of materials/subsystems. -Assist with/coordinate testing of first article configuration. Requirements: -Experience in the medical device/IVD or biotech/pharmaceutical industry in software/system validation, equipment/test method/process validation, quality management, process controls, and continuous improvement methods. -5-10 years in manufacturing, quality assurance, and/or software engineering/validation in an FDA-regulated environment. -Knowledge and working application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, GAMP 5, and 21 CFR Part 11/820. -Knowledge and working application of validation principles and guidelines and industry best practice. -Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment. -Demonstrated analytical problem solving and interpersonal skills. -Ability to work independently or in a team setting. -Ability to communicate effectively across functions and organizational levels. -Ability to successfully prioritize and manage multiple projects across several product lines. -Excellent verbal and written communication/documentation skills. -Strong attention to detail. Preferred Attributes: -ASQ accreditation, Lean Six Sigma, and/or PMP certification. -Experience performing FMEA and Risk Analysis. -Experience with bioinformatics, statistics, Statistical Process Control, and/or Design of Experiments techniques. -Solid understanding of manufacturing processes in high-tech medical device manufacturing. -Experience with Microsoft Office, Microsoft Project, Visual Studio, SAP/ERP, and Manufacturing Execution Systems. -Ability to discuss technical topics with non-technical people. Education: Requires a Bachelors, Masters, or Ph.D./Pharm.D. degree in engineering, science, medicine, or bioinformatics (or equivalent combination of education and experience) and a minimum of 10 years of related experience. EOE / Minorities / Females / Veterans / Disabled
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Additional Info:
All About Us: Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives. Headquartered in San Diego, California, Illumina (NASDAQ: ILMN), is a leading developer, manufacturer, and marketer of next generation life science tools and integrated systems for large-scale analysis of genetic variation and biological function. [Click Here to Access the Original Job Post]