Dave Morris
About Dave Morris
Dave Morris is an Associate Director of Validation at Wave Life Sciences, with over 20 years of experience in Engineering, Validation, and Quality Assurance in the Biotechnology and Pharmaceutical sectors. He has held various roles, including Validation Manager at Shire Pharmaceuticals and Project Manager at ValSource, and possesses expertise in validation protocols and regulatory compliance.
Work at Wave
Dave Morris has been serving as the Associate Director of Validation at Wave Life Sciences since 2019. In this role, he is responsible for overseeing validation processes and ensuring compliance with industry standards. His work includes the development and execution of Validation Master Plans, Technical Studies, and Engineering Test Plans. He applies his extensive knowledge of regulatory requirements and validation protocols to support the company's objectives in the biotechnology sector.
Previous Experience in Pharmaceuticals
Prior to his current position, Dave Morris worked at Shire Pharmaceuticals in various roles. He served as Validation Manager for Validation Maintenance from 2015 to 2019, where he managed validation activities for critical systems. Before that, he was a Senior Validation Engineer II from 2013 to 2015, focusing on validation processes in Lexington, MA. His experience at Shire contributed to his expertise in validation protocols and compliance.
Background in Validation Engineering
Dave Morris has over 20 years of experience in Engineering, Validation, and Quality Assurance within the Biotechnology and Pharmaceutical industries. He has held significant positions, including Project Manager and Senior Validation/Automation Engineer at ValSource, LLC from 2005 to 2008. His background includes conducting spreadsheet validation, performing Part 11 audits, and writing remediation plans, showcasing his comprehensive understanding of validation processes.
Education and Expertise
Dave Morris earned a Bachelor of Science degree in Chemical Engineering from Penn State University. His educational background provides a solid foundation for his extensive career in validation engineering. He is proficient in various programming software, including Allen-Bradley, Siemens, and DELTA V, and is well-versed in Automated Control Systems and Software Validation. His expertise extends to Analytical Methods Validation and Process Validation, incorporating statistical data analysis techniques.
Achievements in Regulatory Compliance
Throughout his career, Dave Morris has developed a strong proficiency in regulatory compliance and validation standards. He is knowledgeable in US 21CFR210, 211, Part 11, GAMP4/5, and ASTM E2500. His work includes performing Risk Assessments, SLIAs, and CCAs, as well as specializing in Process/Cleaning Validation and Consent Decree remediation. His contributions have been instrumental in ensuring compliance with industry regulations in various manufacturing environments.