Selected Case Studies
Two manufacturing challenges. Two different ways of structuring the work. Click either case study below for a closer look at how I approached each challenge and the technical judgment, coordination, and interpretation behind each program.
ILLUSTRATIVE IMAGERY · NOT THE ACTUAL FACILITYRestoring Manufacturing Readiness Following a Major Facility Change
A 12-month program with a 19-person cross-functional team. Equipment requalification and core process revalidation following facility upgrades and relocation of Manufacturing and QC operations while supporting continued clinical supply.
Developing a Risk-Based Continued Process Verification Framework
Monitoring and interpreting process performance at Grifols. Parameter criticality, trends, and technical communication—connecting observations to the right process SMEs at the right time.
Case studies use generalized descriptions, simplified program structures, and synthetic data. Illustrative imagery does not depict actual facilities.