Validation Engineer

By | July 21, 2026

Validation Engineer

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Job ID: 10303349

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Anasco, PR, US

Engineering

Bachelors Degree

Full Time, Temporary

1xx

Experienced (Non-Manager)

On-site

Medical Devices and Supplies

First Shift (Day)

Anasco, PR, US

1xx

Experienced (Non-Manager)

Full Time, Temporary

Medical Devices and Supplies

On-site

Engineering

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking a Validation Engineer to work with one of our top global biopharmaceutical clients in the Anasco, PR area. With us, it’s all about finding the job that’s just right

The Validation Engineer will support and execute validation activities for manufacturing processes, equipment, cleaning, and computerized systems in a regulated environment. The role ensures compliance with applicable regulatory requirements (FDA, ISO, cGMP) and internal quality standards. The ideal candidate has 2–5 years of experience in validation within the medical device, pharmaceutical, or similarly regulated industry.

Resposibilities

  • Develop, execute, and document validation protocols and reports, including:

    • Installation Qualification (IQ)

    • Operational Qualification (OQ)

    • Performance Qualification (PQ)


  • Support process validation activities 

  • Participate in equipment qualification and requalification activities.

  • Perform validation impact assessments for changes (Change Control/CN/CR).

  • Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Engineering, Regulatory).

  • Ensure compliance with applicable regulations

  • Analyze data using statistical tools (e.g., Minitab, Excel) to support validation conclusions.

  • Assist in protocol deviations, investigations, and corrective actions

  • Maintain accurate and complete documentation in accordance with GDP (Good Documentation Practices).

  • Support audits and regulatory inspections by providing validation documentation.

  • Track and report validation project status, timelines, and deliverables.

 

10303349

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