Validation Engineer - Medical Device

Grove Technical Resources, INC

San Diego (CA)

On-site

USD 50,000 - 55,000

Full time

14 days+

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Job summary

A leading recruitment agency is looking for a Validation Engineer for a contract role in San Diego, CA. The candidate will support the qualification and validation of manufacturing processes, ensuring compliance with medical device standards. Responsibilities include protocol development, execution of IOPQ activities, and collaboration with global teams. Ideal candidates should have experience in validation within medical devices and strong communication skills.

Qualifications

Experience with validation protocols in a medical device environment.
Ability to navigate a complex Quality Management System (QMS).
Excellent communication and collaboration skills.

Responsibilities

Update and author qualification and validation protocols.
Ensure compliance with internal procedures and regulatory standards.
Support IOPQ execution at the Ireland site.

Job description

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Lead Recruiter @ Grove Technical Resource | Full-life Cycle Recruiting

Job Title: Validation Engineer

Duration: 6 months + opportunity to extend

JOB DESCRIPTION:

Project Overview:

Client is seeking a validation engineer to support the qualification and validation of a manufacturing line at our Ireland site. This engagement is critical to ensuring compliance with medical device standards and operational readiness for production. The consultant will work closely with cross functional teams across global sites, including SMEs, manufacturing and quality representatives, to execute Installation, Operational, and Performance Qualification (IOPQ) activities

Responsibilities:

Protocol Development & Execution:

Update existing qualification and validation protocols or author new ones based on equipment/process requirements.
Collaborate with SMEs to gather missing requirements and translate them into testable criteria.
Write and align test cases with cross-site teams to ensure consistent execution.

Quality System Navigation:

Navigate Client’s complex Quality Management System (QMS), recognizing and adapting to special cases and exceptions.
Ensure all documentation and activities comply with internal procedures and regulatory standards.

Execution Support:

Expected to travel internationally to the Ireland site to support IOPQ execution.
Participate in dry runs and live execution, collaborating with teams across time zones on equipment execution, material planning and test scheduling.
Generate qualification reports using Client-approved templates and support documentation approval process.
Maintain clear and timely communication with stakeholders across global sites.
Provide regular updates and flag risks or delays proactively
Updated or newly authored qualification protocols.
Executed IOPQ & PV documentation and reports.
Weekly status updates and final summary reports.

Seniority level