Validation Engineer

Job Title: Validation Engineer Location: Santa Clara, CA (Onsite) Duration: 6–12 Months

Job Description:

We are seeking a skilled Validation Engineer with 5–6 years of hands-on experience in medical device or diagnostic equipment manufacturing . The ideal candidate will lead and manage validation activities, ensuring full compliance with regulatory and quality standards.

Key Responsibilities:

Manage end-to-end validation documentation lifecycle including authoring, reviewing, and approving protocols such as:

URS, IQ, OQ, PQ, PV, TMV, RTM, VSR

Change Controls and Periodic Reviews

Ensure alignment with site VMP and ISO 13485 .

Lead cross-functional validation projects for:

Laboratory equipment , facilities , and non-product software supporting molecular diagnostic platforms .

Qualify GxP equipment in compliance with:

FDA 21 CFR Part 11, 211

Manage the complete equipment lifecycle from qualification through decommissioning.

Collaborate with QA and manufacturing teams on:

Deviation Management , Quality Investigations (QI) , and CAPA

Perform Root Cause Analysis (5 Whys, Fishbone Diagram) .

Utilize statistical tools for validation and process robustness:

ANSI/ASQ Z1.4 sampling plans , Normality tests , distribution analysis , control charts , etc.

Apply GAMP 5 risk-based validation framework for:

Assessment and validation of non-product software systems (NPSW) used in manufacturing and quality environments.

Author and maintain required NPSW documentation.

Drive agile change control processes for the release of production documents.

Interface with ViewLinc and Vaisala systems to obtain environmental monitoring data for use in validation and QMS .

Conduct gap analyses on method validation processes, equipment qualification, and environmental monitoring to ensure compliance with industry and regulatory standards.

Support Validation Review Board (VRB) meetings by:

Documenting validation metrics

Tracking goals

Escalating issues and ensuring resolution