QA Validation Engineer – Onsite Contract (8+ mo)

Net2Source; Barceloneta (PR); On-site; USD 62,000 - 65,000; Full time

Job summary

Net2Source seeks a QA Validation Analyst/Engineer for an onsite Barceloneta, PR contract of 8+ months starting soon. You will plan, approve, and execute validation tasks under the Validation Section Manager, ensuring quality program effectiveness at the plant.

The role covers reviewing validation documentation, investigations, plant SOPs, CAPA integration, and coordination with engineering for new installations, with emphasis on cGMP compliance.

Qualifications

• Proficiency with Kaye Validator and TempTales for temperature mapping studies.
• Qualification/validation of temperature and RH controlled chambers (freezers, incubators, cold rooms, refrigerators).
• Experience with Equipment/Utilities/Facilities Validation, periodic reviews and risk assessments.
• Sterilization cycles qualifications for autoclaves and SIP processes.
• Cleaning validation for CIP and automated washer equipment.
• BA Sciences degree and 3-5 years of related experience.

Responsibilities

• Plan and approve validation tasks and lead execution under supervision.
• Review commissioning and validation documentation and investigations.
• Contribute to CAPA process and plant quality systems compliance.
• Support regulatory audits and third party assessments.
• Coordinate with external resources for new installations and validations.
• May supervise contract validation resources as needed.

Skills

Kaye Validator

TempTales

Temperature mapping

Chamber validation

Sterilization cycles

Cleaning validation

Education

BA Sciences

Job description

Net2Source seeks a QA Validation Analyst/Engineer for an onsite Barceloneta, PR contract of 8+ months starting soon. You will plan, approve, and execute validation tasks under the Validation Section Manager, ensuring quality program effectiveness at the plant.

The role covers reviewing validation documentation, investigations, plant SOPs, CAPA integration, and coordination with engineering for new installations, with emphasis on cGMP compliance.