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Scientific. Clinical. Software Engineering

Validation Specialist

Maryland All, MD

Job Type: Engineering Job Number: JN -062020-26946 Region: Maryland All

Job Description

The validation specialist core responsibilities will focus on the coordination and oversight of deliverables associated with shipping qualification activities for globally distributed products. In addition, the specialist should have general validation knowledge to enable support for documentation and studies within process validation. This role will require collaboration and oversight with multi-disciplinary teams across the enterprise to deliver on assignments and deliverables.

Key aspects of this role include definition of shipping qualification strategies and application of worst-case methodology/bracketing with experience with cold chain shipping processes. Other requirements include working knowledge of process validation fundamentals. The role will primarily support the generation of shipping validation strategy documents, protocols and reports.

The individual is expected to work both independently and in collaboration with other organizations within the company. Projects are assigned by management. The individual should possess both a strong Validation background (10 + years) as well as experience leading or participating cross functional, interdisciplinary teams.

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