VALIDATION SCIENTIST / ENGINEER Job in Syracuse 13201, New York US
The Technical Services Validation group is responsible for installation and operational qualification (IQ/OQ) of process equipment, validation of SIP/CIP processes, and validation of critical process utility systems. The Validation Engineer/Scientist carries out validation projects whose scope, regulatory visibility, schedule requirements, complexity require coordination with customers, collaborators, and quality assurance. Responsibilities include execution of validation work arising from change controls, capital projects, shutdown/changeover activity, ongoing revalidation programs and day to day oversight/training of validation contractors. For novel projects, this individual works with Validation Servicesmanagement and Quality Assurance to establish appropriate validation methodologies. The position manages a portfolio of validation projects under strict deadlines to ensure customer success and bulk drug supply. This position leads projects while serving as a point of contact for project stakeholders. As a validation subject matter expert (SME), this individual contributes to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies. Providing support to internal audits and Regularatory inspections as well as completing preparation and resulting work from these activities. The position provides supervision of labor loan, laboratory staff and contract staff through 1-1s, review and approval of their work and training activities. Facilitating their success through appropriate project assignments and developmental opportunities to ensure that customer service needs are met. Maintaining project timelines for group is an integral part of the role. Receiving ideas and requests for new qualification activities, insuring that these are transitioned to others in the group and monitoring progress against customer driven timelines through ongoing internal and external communications. Facilitating the completion of projects and followup items to support customer’s needs and timelines and maintaining KPI requirements is a key to a customer service group such as Validation Services. Maintains SOPs with current practices, industry guidelines, and directives. This includes improving existing systems and developing new ones in alignment with identified needs and requirements. As an experienced SME, the position also acts as a mentor to new employees.
The successful candidate has a BS degree in Engineering, Chemistry, or the Biological Sciences and 4-6 years of experience in support of a GMP biologics or pharmaceutical manufacturing organization. Direct experience or close familiarity with sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping concepts is desired. The successful candidate has experience supervising other as well as working with outside contract firms. Familiarity with or interest in distributed control systems and automation (GAMP) validation concepts may enable this individual to participate in cross-functional validation efforts. A working understanding of lean principles is a plus. Excellent project management, communication, and technical writing skills are required. The successfulcandidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.