Quality Validation Engineer

Position Summary:
The Quality Validation Engineer (Facilities/Utilities) is part of the Quality Assurance team in Quality Department. You will provide facility & utilities validation quality support to Illumina’s manufacturing operations and labs. You will ensure that project and sustaining teams follow the defined facility & utilities validation and system/software life-cycle process which adheres to FDA regulations and ISO standards. As a Quality Validation Engineer, you will be supporting the implementation of continuous improvement to the facility & utilities validation quality processes and monitor the health of implemented facility/utilities. As a key member of the Quality department, you will be responsible for ensuring compliance to Illumina quality policies and procedures

Position Responsibilities:

- Provide quality support to facility & utilities (including software) verification/validation to manufacturing operations and labs.
- Provide quality support for NPI and Product Transfer projects in the manufacturing areas by reviewing and approval of facility & utilities validation and software validation, in accordance to Illumina Procedures and Work Instructions.
- Provide quality assurance support to validation related Quality Investigations, NCRs 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 facilities & utilities (including software) related change requests.
- 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 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:

- 3 years of Quality experience in Facility & Utilities Validation or relevant experience in a regulated environment, in vitro diagnostics/medical device.
- Sound knowledge of Facilities Validation and Risk Management Process.
- Experience with 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.
- Able to deliver quality outputs under mínimal supervision and guidance.
- Influences decision at critical points in time during facility & utilities validation.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:

- Minimum 3 years of related experience with a Bachelor’s degree; or equivalent experience in Engineering.

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.