Software & Validation Quality Engineer 1

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:
The Software & Validation Quality Engineer 1 is part of the Quality Assurance team in Quality Department. This role will provide quality assurance support on system validation, software verification, test method validation and process validation to Illumina’s manufacturing operations and global information systems teams, and to ensure that project and sustaining teams follow the defined system/software lifecycle process and conformance to FDA regulations and ISO standards. As an engineer of the Validation & Software Quality Assurance team, this role will be supporting the implementation of continuous improvement to the system/software validation quality process and monitor the health of implemented system/software. As a key member of the Quality department, the individual in this role will be responsible for ensuring compliance to Illumina quality policies and procedures.

Note: This is not a software testing position.

Position Responsibilities:

- Provide quality support to new and sustaining verification/validation activities focusing on System, Software, Test Method, MES modeling, Process and/or Facilities & Utilities in Manufacturing area of in charge.
- Provide quality support to Development, Lifecycle Management and Manufacturing functions for verification & validation planning and transfer activities. Assist teams in determining verification and validation needs and requirements.
- Provide quality support for automated system/software development projects in the manufacturing areas by reviewing and approval of system/software deliverables, in accordance to Illumina Procedures and Work Instructions.
- Provide quality assurance support to validation related NCR and CAPAs.
- Participate in the development and implementation of validation quality initiatives to address process and system inadequacies to achieve continual quality improvement objectives.
- Support in the review and approval of Manufacturing system/software/process and/or facilities related change requests.
- Support in the transfer of system/software/process from development into manufacturing product support.
- Ensure compliance of validation efforts performed by internal/external validation personnel.
- Ensure validation quality activities are in alignment with company goals, objectives and in compliance with Quality Systems.
- Participates and provides support in customer, regulatory, internal and corporate audits.
- Responsible for escalating potential risks to Management.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices.
- Provide support in the implementation plans for adherence to new regulatory requirements or expectations.
- Perform other duties as may be assigned by Management.
- Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs._

Position Requirements:

- Bachelor’s degree; or equivalent experience in Computer Science, Software Engineering, Informatics, Biological/Life Sciences.
- 0-2 years of Validation Quality and Software Quality Engineering or relevant experience in a regulated environment, in vitro diagnostics/medical device.
- Basic understanding of the applicable regulations and standards: 21CFR 820, 21CFR Part 11, ISO 13485, IEC62304, ISO14971, GAMP5.
- Basic knowledge of System/Software Development Lifecycle Models, Software Verification & Validation, Software Configuration Management (SCM), Process Validation, Test Method Validation, Facilities Validation and Risk Management Process.
- Basic knowledge on statistics, sampling plans, and statistical analysis.
- Experience with Microsoft Office, including Word, Excel and PowerPoint.
- Excellent attention to detail, strong organization skills, and ability to work independently and in teams.
- Excellent interpersonal skills.
- Excellent communication skills, critical thinking and problem-solving abilities.
- Ability to operate flexibly in fast-paced environment.
- Ability to deliver quality outputs under mínimal supervision and guidance.
- Ability to influence decision at critical points in ti