- 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.
CQV / PV
- 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.
- Provided process validation runs in the team.
- Provided 24/7 day coverage.
- Provided Technical Transfer of production from US to Puerto Rico.
- Provided comprehensive cleaning process, design and validation.
- Generated and executed on Clean Hold Study protocols.
- Delivered engineering cleaning process improvements.
- Implemented cleaning chemistry changes.
- 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.