MS&T Director - Sterile Technical SME (Isolators - VHP)

MS&T Director - Sterile Technical SME (Isolators - VHP) Join our team as the MS&T Director - Sterile Technical SME (Isolators - VHP) at Thermo Fisher Scientific . Position Overview This is a full-time, remote role supporting our distributed technical team specializing in Isolator Technology. The role involves providing expertise in isolator technology, aseptic pharmaceutical processes, and process technologies. Location Remote (EU/US). Preferred locations include Monza & Ferentino (Italy), Swindon (UK), Greenville (North Carolina, US), and Bourgoin (France). These sites are key operational locations. Key Responsibilities Manufacturing Support Provide SME expertise in Isolator Technology to help establish division strategy, develop global standards, and harmonize practices across sterile sites. Offer expertise on Decontamination Cycles, Environmental Monitoring, and Cycle Development. Support troubleshooting and root cause analysis at sterile manufacturing sites, promoting technical harmonization. Review aseptic practices and develop improvement plans. Collaborate on implementing new technologies and ensuring successful product launches. Stay updated on GMP, EU, and FDA regulations. Provide technical support for aseptic manufacturing, validation, and sterilization processes. Network Stewardship & New Product Launch Act as the Network SME, working with local and global MSAT teams to define and implement technical standards. Benchmark and extend knowledge within the organization. Author and implement SOPs for relevant technologies. Qualifications and Requirements MSc or equivalent in Pharmacy, Pharmaceutical Technology, Chemistry, or related field. 10 years of GMP manufacturing experience relevant to the role. Strong process understanding of Pharma, GMP, and regulatory standards. Willingness to travel up to 30-40% as needed. Excellent verbal and written communication skills. Ability to influence and lead cross-functional teams. Demonstrated leadership and technical expertise. J-18808-Ljbffr

Location: provincia-di-milano, IT

Posted Date: 6/16/2025