Pandemic Flue New Construction CQV

Aseptic fill finish packaging site in nj. Validation activities wet heat gamma irradiation e-beam ethylene oxide sterilization,Cleanroom qualification and USP performance qualification, smoke studies, liquid filling, ointments filling, potent compound cleaning validation, new product launch, Precession Validation, isolator validation, instrument qualification, temperature controlled units temperature mapping SCADA EMS validation, CSV GAMP VMP lam VMP, Sanitary Agents Validation, Saturated Steam,WFI,Pure Steam, Medical -Grade Air Distribution, BSC, LAF, Facility Decontamination,DataIntegrity -static, Dynamic Complex vision systems, Part 11 electronic records, smart software upgrades, change controls, drawings CAPA investigation, NAF Certified CAPA Investigator, company culture remediation, FDA inspection experience, Shipping Validation, MKT, Advanced temp uniformity analysis-include measured uncertainty in uniformity, dose and LD50 approach to cleaning cytotoxic study determined cleaning limits for detergents, CIP SIP COP Manual cleaning Periodic Reviews,Visual Inspection Certification Program 40 products

Consent Decree Remediation Projects: Commission & Qualification, Engineering Drawings, Packaging. Develop Level-3schedules with weekly dashboard troopers

Integrate three IPS services at Merck West Point: design, construction and CQV. In addition for Merck GEA West Point design/ build projects to adopt the Integrated Approach in ISPE C&Q Baseline Guide. My job was to convince VPs to adopt this approach over the traditional 100% backend testing. IPS Principle Officers and I presented its benefits “to buy down risk” to the back end of the project which often spirals out of control for cost and schedule. The VPs would set up action committees to implement the approach which I would facilitate. The idea was to convert West Point then move on to the other sites

Document report to Exec Construction Quality and retrofit design quality

Conduct Periodic Reviews for Bldg 211 vaccine validation protocols

Support Design/Build with contract validation services

International Field Validation Project Manager-Injectables, Vaccines, OSD