Jay Parekh

Bioprocess Specialist Ii @Hyde Engineering + Consulting

Toronto, ON, CA

Developed and executed comprehensive cleaning validation plans, including risk assessments and evaluation of system cleanability through flow path reviews.• Optimized cleaning cycles to minimize water, chemical, and time usage, resulting in increased operational efficiency and sustainability.• Investigated protocol deviations and non-conformances; conducted impact assessments on validation studies and prepared detailed investigation reports.• Coordinated and managed sampling plans across multiple concurrent projects.• Authored and executed cleaning validation protocols for complex systems, including fermenters, tubular centrifuges, and disc stack centrifuges.• Performed critical sampling techniques such as rinse and swab sampling as part of cleaning validation studies.• Analyzed and interpreted system performance data to assess cleaning validation outcomes and compiled comprehensive final report packages.• Reviewed GxP documentation, including specifications, engineering drawings, SOPs, master plans, and validation records.• Actively promoted cGMP and regulatory compliance throughout project activities.• Conducted system and P & ID walk-downs; generated layout drawings and process maps to support validation efforts.• Proposed design improvements to reduce utility consumption and cleaning time while maintaining compliance and performance standards.