Illumina

Validation Engineer 1

US - California - San Diego, USA

H1B sponsorship available$63k-$94kDetected 96 days ago

StatisticsGMPFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingAdaptability

About the role

What if the work you did every day could impact the lives of people you know?
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.
Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

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.
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.
We're seeking a driven and talented Validation Engineer to support manufacturing operations through close collaboration with cross‑functional partners.
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.

Requires a bachelor's degree or master's degree in engineering or science. 1-2 years of related experience 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.

The estimated base salary range for the Validation Engineer 1 role based in the United States of America is: $62,900 - $94,300.
Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission.
We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race.
Working at Illumina means being part of something bigger than yourself.
Every person, in every role, has the opportunity to make a difference.

This listing is sourced directly from Illumina's careers page and normalized into a canonical job model.