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Director, Validation | Engineers Service in Gaithersburg MD | 6214264945

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Director, Validation

Gaithersburg, MD

Emergent BioSolutions (NYSE: EBS), headquartered in Gaithersburg, Maryland, is a global life sciences company that provides a diverse portfolio of specialty products and services that address public health threats. The company develops, manufactures, and commercializes medical countermeasures (MCM) against chemical and biological, (CBRN) threats, as well as explosive-related threats and existing and emerging infectious diseases (EID). In 2018, the company diversified the scope of its public health threat mandate significantly by acquiring Adapt Pharma, the maker of NARCAN® Nasal Spray for opioid overdose reversal, and PaxVax, the maker of Vivotif® and Vaxchora®, which are marketed travelers vaccines for typhoid and cholera, as well as a number of R&D programs at various stages of development. Emergent BioSolutions continues to drive innovation and achieve significant growth YOY—growing from a company with only one product and less than $300M in revenue in 2012 to a broader base with 10 products that are now marketed or procured globally. The company is on target to exceed $1B revenues for 2019, one year ahead of plan, while advancing the founding mission to protect and enhance life. The company operates through four business units: * VACCINES* THERAPEUTICS* DEVICES* CONTRACT DEVELOPMENT & MANUFACTURING Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.JOB SUMMARY Develop and implement harmonized validation processes and practices across the company. Assist in governance of validation processes across the sites. Develop team / network of Validation SMEs capable of supporting Global Validation initiatives and assisting site's with complicated validation issues. Provide strategic leadership to the company's Engineering, Facilities and Validation organization. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Implement harmonized validation process and practices across the company* Develop validation policies and global SOPs that reflect company and industry best practices* Remain current on industry and regulatory trends, incorporating emerging regulations into policies and procedures* Partner with site EFV Directors and Validation Managers on the implementation of harmonized practicesAssist in governance of the company's validation processes and project portfolio* Monitor and influence the collective performance of the organization's Site Validation Teams on-going activities* Provide validation support and guidance to major capital projects and corporate initiatives* Manage implementation of major validation projectsDevelop the company's validation expertise* Identify internal expertise in all aspects of validation (cleaning, CSV, etc) across the company* Hire, develop, or contract resources to fill gaps between the organization's validation needs and capabilities* Facilitate development of the organization's validation capability by coordinating cross site sharing and external learning opportunitiesProvide strategic and tactical leadership to the EFV organization* With other EFV leaders, jointly own the EFV goals of providing excellent service to the sites while harmonizing and optimizing EFV systems and practices* Maintain routine contact with site EFV Directors and site Validation ManagersRoutine travel (
September 16 on Contact RH
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