Samitha Kulathunga
Lead QA Specialist - Global Technical Quality at Novavax | Gaithersburg, Maryland, United States
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Samitha Kulathunga is a seasoned Validation Engineer at Novavax Inc., where he plays a pivotal role as a Validation Specialist - IV within the biopharmaceutical sector. With a robust background in physics from the University of Maryland College Park, Samitha has honed his expertise in critical areas such as Steam Sterilization, Downstream GMP, and e-Validation. His current responsibilities involve applying a risk-based approach to the qualification and validation program, ensuring that all processes meet stringent regulatory requirements and industry standards.
In his role, Samitha is instrumental in developing, reviewing, executing, and approving a diverse array of qualification documentation for systems, utilities, and infrastructure. His meticulous attention to detail and commitment to quality assurance are reflected in the routine programs he maintains, which comply with Novavax's Standard Operating Procedures (SOPs) and relevant current Good Manufacturing Practices (cGxP) regulations. As a Subject Matter Expert (SME) for manufacturing systems—including Autoclaves, Steam Sterilization processes, Equipment Qualification, and Downstream Equipment—Samitha oversees the entire system lifecycle, from initial validation through to ongoing compliance.
His proficiency in Clean Utility Validation and experience with external audits further enhance his capability to uphold the highest standards of quality and safety in biopharmaceutical manufacturing. Samitha's contributions not only ensure operational excellence but also support Novavax's mission to deliver innovative vaccines and therapeutics to the global market. With a strong foundation in validation engineering and a passion for advancing biopharmaceutical processes, Samitha Kulathunga continues to make significant strides in enhancing the quality assurance landscape at Novavax Inc.
Lead QA Specialist - Global Technical Quality at Novavax in December 2024 to Present
Validation Specialist - IV at Novavax in September 2021 to December 2024
Validation Engineer at GSK in September 2017 to September 2021
Cleaning Validation Engineer at GSK in July 2016 to September 2017
Biopharmaceutical Manufacturing Associate - Shift Lead at GSK in April 2014 to June 2016
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University of Maryland, Bachelor’s Degree
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Autoclave
Equipment Validation
Clean Utility Validation
External Audits
GMP
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Discover more about NovavaxWhat is Samitha Kulathunga email address?
Email Samitha Kulathunga at [email protected], [email protected] and [email protected]. This email is the most updated Samitha Kulathunga's email found in 2026.
What is Samitha Kulathunga phone number?
Samitha Kulathunga phone number is 2406723195.
How to contact Samitha Kulathunga?
To contact Samitha Kulathunga send an email to [email protected], [email protected] or [email protected]. If you want to call Samitha Kulathunga try calling on 2406723195. (updated on September 04, 2024)
What company does Samitha Kulathunga work for?
Samitha Kulathunga works for Novavax
What is Samitha Kulathunga's role at Novavax?
Samitha Kulathunga is Lead QA Specialist - Global Technical Quality
What industry does Samitha Kulathunga work in?
Samitha Kulathunga works in the Pharmaceuticals industry.
Samitha Kulathunga Email Addresses
Samitha Kulathunga Phone Numbers
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