Tim Houck is a seasoned Principal Validation Engineer at Genzyme, where he plays a pivotal role in ensuring the integrity and compliance of biotechnology and pharmaceutical manufacturing processes. With over 20 years of extensive experience in the validation field, including nine years in validation management,...
Tim Houck is a seasoned Principal Validation Engineer at Genzyme, where he plays a pivotal role in ensuring the integrity and compliance of biotechnology and pharmaceutical manufacturing processes. With over 20 years of extensive experience in the validation field, including nine years in validation management, Tim brings a wealth of knowledge to the Quality Assurance Validation (QAV) Department. His expertise encompasses a broad spectrum of validation activities, including cleaning validation, process validation, and aseptic filling validation, all of which are critical to maintaining the stringent cGMP standards required in the industry.
In his current role, Tim is responsible for reviewing and approving comprehensive cGMP commissioning, qualification, and validation documentation, which includes plans, protocols, reports, and standard operating procedures (SOPs). He serves as the final Quality Unit approval signatory, ensuring that all documentation meets both US and international regulatory requirements. Tim's meticulous attention to detail and deep understanding of change control processes enable him to effectively manage document and facility changes, thereby safeguarding the quality and reliability of manufacturing operations.
Tim's technical acumen extends to specialized areas such as mammalian cell culture and microfiltration, where he has successfully led key projects aimed at optimizing validation processes and enhancing operational efficiency. His commitment to quality assurance not only supports Genzyme's mission to deliver safe and effective biopharmaceutical products but also positions him as a trusted leader and mentor within the organization. As he continues to navigate the complexities of the validation landscape, Tim remains dedicated to fostering a culture of compliance and excellence in the biotechnology sector.
