Posted 1 month ago
Validation Associate (Boston, MA)
Guaynabo, Guaynabo, Puerto RicoRemoteFull-time
AI Summary
A Validation Associate executes validation and qualification activities for equipment and computerized systems in regulated industries, performing periodic reviews, deviation handling, change control, risk assessments, and reporting.
About this role
Validation Associate (Boston, MA)
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.
- 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.
- Validation Master Plan ownership.
- 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.
- Execute qualification/validation for new/modified equipment.
Qualifications
BS in Science or Engineering
Additional Information
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
Skills
CAPAChange ControlComputerized SystemEquipment ValidationPeriodic ReviewQualificationRisk AssessmentValidation
