Validation Engineer 1

Illumina • San Diego, CA

4d

About The Position

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. We're seeking a driven and talented Validation Engineer to support manufacturing operations through close collaboration with cross‑functional partners. This role is critical in defining, implementing, and maintaining validation activities that ensure robust, compliant manufacturing processes and systems. The ideal candidate brings experience in quality engineering, process development, or process engineering, and can quickly develop while working independently within a fast‑paced, team‑oriented environment. As a Validation Engineer, you will play a key role in driving overall quality performance and compliance by leading validation deliverables and activities across manufacturing systems and processes.

Requirements

• 1-2 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech) is preferred.
• Knowledge and working application of FDA and cGMP requirements.
• Knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management.
• Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable.
• Knowledge and working application of standard operating procedures.
• Demonstrated ability to accomplish goals in collaboration with cross-functional teams.
• Demonstrated analytical problem-solving skills.
• Computer competency in MS Office.
• Excellent interpersonal, written, and verbal communication skills.
• Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically.
• Requires a bachelor’s degree or master’s degree in engineering or science.
• 1-2 years of related experience is preferred.

Nice To Haves

• ValGenesis eVLMS and Teamcenter PLM experience is a plus.

Responsibilities

• Represent the Consumable Validation group as the validation subject matter expert in manufacturing operations value streams and project teams, ensuring validation requirements and deliverables are communicated to the teams.
• Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.
• In collaboration with end users, process owners, quality engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems.
• Write reports summarizing results and statistics for all equipment and process validation projects.
• Be accountable for timely completion of all validation deliverables in accordance with manufacturing needs and project timelines.
• Learn and understand the applicable technology and engage in technical discussions.
• Provide consultation to other departments performing validation activities.
• Provide input for creation of requirements documents.
• Actively participate in creation of risk management documents such as pFMEA for systems and processes.
• Perform job function in compliance with the internal procedures and applicable external regulations and standards, e.g. FDA QSR, ISO-13485.
• Initiate and execute controlled document change requests.
• Execute other related tasks assigned by the supervisor.

Benefits

• We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
• We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees