SIP: Cycle development and PQ of new production facility equipment CPE (closure processing equipment) for new filling factory, writing protocols, participating in execution and writing reports. DQ, FAT, SAT of new production facility for both process and CIP/SIP processes. Participation in design of equipment and in design of automation system to the new production equipment. Review of FDS’s, participation in FAT and SAT of automation system for the downstream process, the CIP process and the SIP process. Making the CIP/SIP qualification strategy. Writing OQ and PQ protocols. URS, DQ, FAT, IQ, OQ of new autoclaves and utensil washer. Participation in design process to DQ over FAT to the IQ and OQ. Making reviews, writing protocols and physical participation in FAT. SIP PQ of new process upstream facility: planning and execution of the SIP. Making qualification strategy, writing rationales, VPP, procotols.