What are the responsibilities and job description for the Validation Project Manager position at US Tech Solutions?
Duration: 10-11 Months Contract(With possible extension)
Job Description:
Note: Validation of Computer Systems
Do not exceed 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)
Responsibilities:
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 (3134 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.
Qualifications:
- Develop and maintain Validation dashboard.
- Develop Project Schedule
- Computerized Systems Validation Master Plan
- Validation Assessments for any change controls linked to systems.
- Validation of the Wireless data loggers used for temperature mapping.
- Validation IOPQ for the wireless data loggers
- Validation procedures specific to Computerized Systems
- Periodic reviews (3134 systems)
- Decommissioning of the Hanwell EMS System
Education:
- High School diploma required
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Name: Aishwarya Tiwari
Email: aishwarya.t@ustechsolutionsinc.com
Internal Id: 25-31218
Salary : $90 - $98
