Katalyst CRO

Validation Engineer III

Waltham, MA, US

4 months ago
Save Job

Summary

Responsibilities

  • Local Validation Program Maintenance.
  • QAV Documentation Review and Approvals for local and CMO's.
  • CS Periodic Reviews planning and approvals.
  • QA GMP IT Support for DI and CS INF activities.
  • Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation).
  • QRFR's Generation.
  • Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation.
  • SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective.
  • Validated Equipment Requalification, Modification/ Remediation/ Decommissioning.
  • Software Upgrade(s).
  • Validation SME support for QMS Impact Assessments and Change Actions.
  • Validation Support for Risk Assessment on Equipment.
  • AdHOC Validation Support on Global Computerized Equipment Deployment.
  • Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations.
  • The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines.
  • URS.
  • Registration/ Calibration form.
  • SCCA forms.
  • Risk Assessment (for equipment with CSV).
  • Configuration Spec. (for equipment with CSV or as applicable).
  • Vendor qualification package (if purchased).
  • Global/Digital CS System QAV Representation and deliverables approver.
  • Internal Validation protocol.
  • Requirements Traceability Matrix.
  • Internal Final Report.
  • Reports will be provided within client Quality Management System and email.
  • Reports to channel through Quality Assurance Validation staff.

Requirements:

  • Engineer or related BSc/BEng degree.
  • Previous Pharma Experience required.
  • Previous QA Validation experience Required.
  • Minimum 10-15 years of experience.
  • Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing.
  • Previous experience QAV department in drafting, reviewing, approving documentation.

How strong is your resume?

Upload your resume and get feedback from our expert to help land this job

MORE JOBS LIKE THIS

People also searched: