What are the responsibilities and job description for the Validation Maintenance Support position at Randstad Global Capability Center?
Contract role for 6 Months
Validation Maintenance Support - 2025
301 Binney Street Cambridge MA 02139
Scope:
- Periodic Review of 34 Commercial Off The Shelf (COTS) systems
- Summer Mapping of the GMP warehouse
- Winter Mapping of the GMP Warehouse
- Decommissioning of Legacy Environmental Monitoring System (Hanwell)
- Asset Introduction and Validation of Wireless Data Logger software and probes (ellab)
Roles/Responsibilities:
Validation PM
- Track spend against deliverables.
- Develop and maintain Validation dashboard.
- Adjust resources based on demands.
- Manage Day to Day.
- Coordinate with fellow Validation leads.
- Generate and reconcile Invoices.
- Develop Project Schedule.
Senior CSV Lead
- Update the Computerized Systems Validation Master Plan
- Provide Validation Assessments for any change controls linked to systems.
- Develop validation protocols in support of any change controls.
- Execute Validation protocols related to change controls.
- Close/Update Change Control tasks assigned to Validation.
- Reviewer/approver of completed periodic reviews.
- Oversee/Support the Validation of the Wireless data loggers used for temperature mapping.
- Develop and execute the Validation IOPQ for the wireless data loggers.
- Oversee the development, revision, and approval of System Risk Assessments, Design Qualifications, Functional and Configuration Specifications, System Classifications, etc.
- Support the role out of the Kneat system at the Binney Street site.
- Reviewing and revising as needed Validation procedures specific to Computerized Systems Validation which include periodic review of the procedures.
- Act as a backup for Spreadsheet Validation
- Decommissioning of the Hanwell EMS System
CSV/Validation Engineers
- Maintain the Site Validation Master Plan
- Provide Validation Assessments for any change controls linked to equipment, facilities, utilities.
- Develop validation protocols in support of any equipment, facilities, and utilities related change control.
- Execute Validation protocols related to change controls.
- Execute periodic reviews (31-34 systems)
- Update the Periodic Review and Requalification schedule as periodic reviews as applicable.
- Oversee, shadow, and approve vendor execution related to equipment modifications.
- Develop, execute and approve wrapper protocols.
- Support seasonal mapping (winter and summer) of the GMP Warehouse
- Reviewing and revising as needed procedures specific to commissioning and Qualification which include periodic review of the procedures.
Salary : $7 - $85
