Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer to write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment. The engineer will write and execute qualification protocols for new equipment and decommissioning protocols for old equipment.
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Responsible for leading the strategic direction, development, implementation, and management of food safety and quality assurance programs, the role ensures that Chomps' products meet all regulatory requirements and industry standards while maintaining the highest level of quality and safety. The ideal candidate will have extensive experience in food safety, quality control, and regulatory compliance within the food industry.
Build team capacity and individual testing skills providing scalable structure. Lead the team in setup and compliance with quality assurance standards. Monitor and improve quality assurance processes and procedures in line with latest testing technologies. Facilitate communication within different technical teams within engineering. Participate in presales initiatives and project estimations for testing activities.