Senior Validation Engineer

Basic Function and Scope of the Position:
Responsible for supporting product transfer, instrument manufacturing, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement. The Engineer will have primary responsibility for driving overall instrument quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program. The engineer is also responsible for risk assessment, strategy development, execution & commissioning of day to day sustaining and product validation activities.

Tasks and Responsibilities:

- Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
- Write reports summarizing results and statistics for all validation projects.
- Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
- Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
- Monitor and drive corrective action and continuous improvement activities that directly impact validation performance measures.
- Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels.
- Coordinate with end users and process owners to lead development of validation protocols.
- Participate in project management meetings as Validation representative determining validation requirements, as needed.
- Support and drive activities to ensure successful product transfer into manufacturing.
- Support instrument setup, calibration and final system integration test.
- Sustain databases of instrument validations activities (Valgenesis and Internal Team Shared folder).
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes and equipment.
- Collaborate and provide consultation to other departments performing validation activities
- Coordinate with Validation, Engineering and Quality Teams to collect and analyze existing validation deliverable for Instrument systems and processes
- Ensure compliance with Validation procedures and Illumina’s Quality Management system
- Ensure validation program meets requirements of FDA and ISO
- Provide guidance and supervision to junior staff.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Preferred Educational Background:

- Requires a Bachelors, Masters or PhD. degree in engineering or science with a minimum of 5 years of related working experience.

Preferred Experiential Background:

- Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.- Demonstrated ability to accomplish goals while working across departments is required.
- Demonstrated strong analytical problem solving (CAPA), team and communications/interpersonal skills/good analytical and troubleshooting skills.
- Proficient in engineering tools such as, statistical analysis, design of experiments, product, FMEA and Risk Analysis and process capability analysis.
- Experience in the biotech instrument, medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.-
- Computer competency in Word, Excel, Power Point, Statistical Software and databases
- Experience with statistics, Statistical Process Control and DOE techniques is a plus.

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.