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Illumina is looking for a driven, talented Engineering Manager to join our Consumables Manufacturing Validation Engineering group. As the leader of the Computer Software/System Validation team, this person will work in a dynamic, team-oriented environment and play a significant role in the implementation and validation of software/systems used in the consumables manufacturing lines. This person will lead a team of Validation Engineers to establish and maintain the validated state of the Computer Systems and Process Software utilized on the consumables manufacturing lines within the site and coordinate / support technology transfer to other sites, as needed. This leader will partner cross-functionally with R&D, Quality, Production, and other engineering groups in the design, development, launch and validation of new manufacturing process and will also provide support to manufacturing to satisfy the quality and process/software validation requirements for existing products in a rapid growth environment.
- Provide leadership and direction to the consumables Process Engineering team to accomplish all team goals and objectives.
- Maintain staff by recruiting, selecting, and training employees. Maintain a safe, secure, and legal work environment.
- Manage team development through training, coaching and career mapping. Develop personal growth opportunities.
- 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 systems and processes against cGMP and ISO 13485 requirements for process validation and 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)
- Maintain validated state under Site Validation Master Plan and update Site Validation Master Plan as needed.
- Collaborate with peers and stakeholders to identify opportunities for process improvement.
- Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites.
- Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures.
- 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.
- Author software/system validation plans, protocols, and reports for consumables manufacturing and release.
- Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports.
- Assist with documentation and resolution of deviances and variances 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.