Candidate will work with MSAT Process Validation group with the following responsibilities:
Responsible for performing data mapping of Continued Process Verification (CPV) software.
Assist in the development and implementation of CPV data mapping strategies.
Collect, organize, and map process data and QC data from various sources to ensure accurate and comprehensive data sets.
Perform CPV evaluation and generate CPV reports.
Generate new work instruction and curriculum to implement new CPV software.
Maintain accurate and up-to-date documentation of CPV activities and data mappings.
Support other process validation projects (as needed) to ensure processes are validated to required standards.
Reviews and interprets data for accuracy for completed validations/re-validations and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
Manage all moderate troubleshooting efforts for protocol discrepancies.
Basic understanding of GMP (Good Manufacturing Practices) and regulatory guidelines.
Proficiency in Microsoft Office including Word, Excel, and Visio.
Experience with Minitab or similar statistic analysis software is preferred
Process validation background is preferred.
Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes is preferred.
Excellent technical writing and verbal communication skills
Strong analytical and problem-solving skills.
Ability to work effectively in a team environment.
Demonstrate ability to manage multiple activities while maintaining a high level of organization.
Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.