• SCOPE

    PROJECT MANAGEMENT

    DELIVERABLES

    • Managed the introduction of single-use technology into a site for buffer formulation and storage.
    • Provided assessments of legacy systems and equipment for a new engineering lifecycle and risk analysis.
    • ¬†Delivered assessments to determine the necessary level of remediation.
  • SCOPE

    CQV / PV

    DELIVERABLES

    • Provided IQ and OQ of new equipment installation.
    • Provided commissioning, qualification and validation of a new site.
    • Assisted in the backlog of re-qualification efforts and change controls.
  • SCOPE

    ENGINEERING SERVICES

    DELIVERABLES

    • Provided process validation runs in the team.
    • Provided 24/7 day coverage.
    • Provided Technical Transfer of production from US to Puerto Rico.
  • SCOPE

    CLEANING DEVELOPMENT

    DELIVERABLES

    • Provided comprehensive cleaning process, design and validation.
    • Generated and executed on Clean Hold Study protocols.
    • Delivered engineering cleaning process improvements.
    • Implemented cleaning chemistry changes.
  • SCOPE

    CONSTRUCTION QUALITY

    DELIVERABLES

    • Provided 3rd party QAQC Program to include visual and video weld inspections.
    • Performed system analytical testing.
    • Performed cleanroom NEBB certification and filter maintenance.
    • Provided material inspection and electronic turnover package.