US

Project Manager III - Contract, Hybrid

Cambridge, Massachusetts
Work Type: Contract
Alphanumeric is hiring a PROJECT MANAGER  - Level 3 to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements; working with their CSV system.

This role is available through a 10 month-duration W2 contract (with possibility for extension).
We do not offer work visa sponsorships for this role.

The compensation on offer for this role is within a range of between $70 and $80 per hour.

This role is working on hybrid basis, with around 80% of the time in the office and 20% WFH.

Scope of position:
  • 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)
Job Req: Roles/Responsibilities:
  • 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.
Other responsibilities within the scope of the project:
  • 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
  • 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

Submit Your Application

You have successfully applied
  • You have errors in applying
By clicking Submit Application, I acknowledge having read your Privacy Policy and agree to storing and processing my data for this application.