Posted 1 month ago
Validation Lead (Boston, MA)
Guaynabo, Guaynabo, Puerto RicoRemoteFull-time
AI Summary
Lead validation activities for equipment and computerized systems in regulated pharmaceutical/biotech environments; execute qualification/validation, lead risk assessments, and oversee change control and reporting.
About this role
Validation Lead (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 SystemEquipmentQRAESQualificationRisk AssessmentValidation
