Massachusetts Institute of Technology

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I have worked in the Biotechnology industry for over nineteen (19) years. During that time I have worked in various disciplines employed directly by operating companies and within various consulting roles. Within the last five years of my career I have been responsible for establishing a high performing validation group of greater than 50 people (12 full time employees) during the start up of one of the world's largest biotechnology facilities. After that startup I lead a large team of engineers on a regular basis (~25 people). I have been recognized as providing noteworthy leadership and value-added services to all client groups. I was directly responsible to ensure appropriate standards were established and adhered to for all validation activities in respect to IQ, OQ, CIP PQ and SIP PQs at two manufacturing plants and a central utilities building in Rhode Island. I have developed validation systems, programs and procedures at the site to promote, facilitate and ensure compliance with the companies Quality Manual, Operational Standards, domestic and international GMPs and regulatory industry standards. I have also been recognized as a proactive manager that initiates and leads cross-site, cross-functional and global initiatives and validation projects.