Validation Lead: Quality Risk & Automated Systems

Validation & Engineering Group; Guaynabo (PR); On-site; Full time

Job summary

A leading services supplier in engineering and validation located in Puerto Rico is seeking a qualified candidate for periodic reviews and assessments of equipment and computerized systems. Responsibilities include managing deviation and CAPA ownership, conducting validation change control assessments, and leading Quality Risk Assessments. A Bachelor's degree in Science or Engineering is required. This job offers the opportunity to work in a dynamic environment supporting various industries.

Qualifications

• Bachelor's degree in Science or Engineering required.

Responsibilities

• Review equipment periodically.
• Assess controlled temperature chambers regularly.
• Perform annual product review reporting for commercial equipment.
• Manage deviation and CAPA ownership related to validation maintenance.
• Conduct validation change control assessments.
• Lead Quality Risk Assessments for equipment and automated systems.
• Track performance metrics and report results.

Education

BS in Science or Engineering

Job description

Validation & Engineering Group,Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical,and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.

Job Description

• Periodic review of equipment.
• Periodic review of controlled temperature chambers.
• Periodic review of computerized system – Includes assessing systems to be enrolled in computerized system periodic review.
• Annual Product Review (systems list) reporting for commercial equipment.
• Deviation and CAPA Ownership and Support related to Validation Maintenance issues.
• Validation Change Control assessments.
• Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES).
• Performance tracking and metric reporting.

Qualifications

BS in Science or Engineering

Additional Information

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

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