Michael Mainini

Blending his education in Marine Engineering and Business with leadership. Michael is a graduate of the California Maritime Academy with a degree in Marine Engineering advancing to the position of First Engineer. Michael continued his education achieving an MBA in Management from John F Kennedy University.

Serving as a Marine Engineer  provided Michael with extensive hands-on expertise in the operation and maintenance of complex mechanical systems. In parallel, Michael served as an officer in the United States Naval Reserve and was honorably discharged obtaining the rank of Lieutenant.

 Michael applied his mechanical and operational experience to develop advanced maintenance programs and lead strategic facilities projects. Key responsibilities included participating in FDA pre-approval meetings at FDA offices and Phase 3 clinical site audits, gaining significant experience in regulatory compliance. His specializations include cleanroom environments, and utility systems including Deionized Water and Water for Injection (WFI). 

Michael's career progressed into senior leadership roles, culminating in positions such as Senior Director of Facilities, EHS, and Security. He has supported emerging and established companies across the Biopharmaceutical, Pharmaceutical, and Medical Device sectors, with a focus on GxP readiness and audit preparedness for both FDA and ISO regulatory bodies.

With extensive experience in facilities strategic planning, site selection, construction, startup, commissioning, and decommissioning, Michael led multi-functional teams in the U.S. and internationally. He has extensive knowledge in implementing and validating CMMS, IWMS, and LMS platforms (with over 15 system implementations). In addition, his extensive experience drove standardizing soft services programs including janitorial and maintenance operations. His construction portfolio includes managing a $41 million project for headquarters and manufacturing facility project.

• Selection of Facilities software, IWMS, CMMS, LMS and stack streamlining.
• Regulatory readiness, GMP, ISO. 
• Commissioning and decommissioning sites.
• Move in and start up new sites

• Pacific Biosciences – Sr Director of Facilities, EHS and Security
• Johnson & Johnson – Director of West Coast Facilities, Cordis Medical Device Division
• Genitope – Director of Facilities, EHS and Security
• Lynx/Solexa – Director of Facilities, EHS and Security 
• Aviron - Director of Facilities, EHS, Security and Lab Services
• Sequus Pharmaceuticals – Director of Facilities, EHS and Security
• Scios Inc – Director of Facilities
• Xoma Corp – Maintenance Manager