Validation Engineer: Pharma Equipment & Utilities Expert

Pinnaql; Cayey (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group Inc, a Pinnaql company, seeks a Validation Specialist/Engineer with hands-on pharma/biotech equipment and utilities qualification experience. The role focuses on on-site testing, protocol development, and delivering inspection-ready documentation.

Expect coordination with operations and engineering teams. Responsibilities include FAT, IQ, and PQ execution for water systems; developing amendments to protocols and final reports with deviations and CAPA notes.

Qualifications

• Hands-on validation experience in pharma/biotech equipment and utilities.
• Strong understanding of GMP and quality systems (QMS, CAPA).
• Experience with FAT/IQOQ/PQ execution and on-site testing.

Responsibilities

• Review and amend existing validation protocols for equipment and utilities.
• Plan and execute FAT, IQ, and PQ activities; generate documentation.
• Prepare final validation reports with deviations, root cause analysis and CAPA recommendations.
• Coordinate with operations and engineering to deliver inspection-ready files on site.

Skills

Validation

FAT

IQOQ

PQ

Documentation

Education

BS in Engineering/Chemistry/Biology

Tools

MS Word

Excel

Job description

Validation & Engineering Group Inc, a Pinnaql company, seeks a Validation Specialist/Engineer with hands-on pharma/biotech equipment and utilities qualification experience. The role focuses on on-site testing, protocol development, and delivering inspection-ready documentation.

Expect coordination with operations and engineering teams. Responsibilities include FAT, IQ, and PQ execution for water systems; developing amendments to protocols and final reports with deviations and CAPA notes.