Engineering Manager with a unique combination of experience in Biotech/Vacccine Manufacturing facilities operations, design, construction, commissioning, qualification and start-up. Specialized in all engineering activities and aspects of Pharmaceutical Development labs, API/Formulation facilities, Aseptic Filling (syringes/vials), Packaging Systems, and Clean Process utilities. Process SME versed in Aseptic Manufacturing and knowledgeable of cGMP's. Known for a creative approach to problem solving, strong collaboration with project teams and establishing outstanding relationships with colleagues, contractors and work associates. Proven ability to effectively solve and communicate practical solutions to complex problems.

Senior Director, Project Management @ Primary responsibilities include managing and supporting the global staff of project managers, project risk management, project financial performance, client satisfaction and training on the use of project management tools to ensure consistent project successes across all regions and geographic locations. Management of Quality Assurance and Design Administrative services. From June 2014 to Present (1 year 7 months) Greater Philadelphia AreaSenior Director, Design Operations @ Manage design operations and ensure the quality execution of the companies portfolio of projects. From October 2012 to Present (3 years 3 months) Greater Philadelphia AreaDirector, Project Management @ Manage project management group and ensure the quality execution of the companies portfolio of projects. From September 2011 to October 2012 (1 year 2 months) Greater Philadelphia AreaProject Manager, Senior Associate @ Managing all design aspects of capital projects for a diverse portfolio of clients. Specializing in facility renovations, brown field and green field facility expansions. Specializing in the management of people, design and operations of vaccine manufacturing facilites. From October 2010 to September 2011 (1 year) Greater Philadelphia AreaProject Engineering Manager @ Global Engineering site leader (Vaccine, Consumer, Site Utilities) supporting all Capital Projects >$500k, Facility Renovations, Global Reliability Program, Energy Conservation Initiatives, Integrated Facilities Management (IFM), Maintenance Stores (MRO), Common Interest Groups (CIG's). Key accomplishment was the design and construction of a vaccine formulation expansion increasing formulation capacity and installed flexibility to increase batch size. From October 2009 to July 2010 (10 months) Project Engineering Manager @ Managed engineering design teams (colleagues and contractors) on the design, construction, FAT's, commissioning and start-up of Biotech/Pharmaceutical manufacturing facilities. From May 2001 to October 2009 (8 years 6 months) Director of Aseptic Manufacturing Design Technology @ Managed group of process engineers on all activities pertaining to the design of aseptic manufacturing facilities. From January 2000 to April 2001 (1 year 4 months) Manager of Aseptic Manufacturing Design Technology @ Managed process SME's in the development of documentation and design for aseptic manufacturing facilities. From August 1995 to January 2000 (4 years 6 months) Project Engineer @ From April 1985 to August 1995 (10 years 5 months)

MS, Engineering Management @ Drexel University From 1997 to 2002 BS, Electrical Engineering Technology @ Fairleigh Dickinson University From 1982 to 1987 Louis Isernia is skilled in: Validation, GMP, Pharmaceutical Industry, FDA, Change Control, Biotechnology, CAPA, Technology Transfer, Project Management, V&V, Computer System Validation, Quality System