Validation Scientist

Summary of Role: Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
Responsibilities:Advanced validation knowledge (equipment qualification, cleaning, sterilization).Applies extensive technical validation expertise and has full knowledge of other related disciplines.Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.Exercises considerable latitude in determining technical objectives of assignment.Completed work is reviewed from a relatively long- term perspective, for desired results.Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.Essential to the completion of broad programs and projects. Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.Leads efforts of a group of peers and directly supervises staff or project resources.Guides the successful completion of major programs and may function in a project leadership role.May be expected to directly supervise staff or project resources.Represents the organization as the prime technical contact on contracts and projects.Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.Understands regulatory trends in industry and is able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body. Represents the organization as the technical expert to endorse the organization's validation programs and practices.
Education: Bachelor’s degree in Engineering or a Scientific field.
Skills:In-depth knowledge of validation processes and requirements.Interacts effectively with variety of communication and working styles.Ability to independently determine when additional internal resources are required to solve problems.Ability to handle multiple projects at one time.Demonstrated Skills in the following areas: schedule development, facilitation, collaboration.Basic project management.Completion and follow-up.Technical expertise areas of validation engineering.Ability to independently determine when additional external resources are required to solve problems.Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.Working knowledge of financial analysis tools.Ability to delegate and manage the project work of others.Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation, collaboration, project cost development, conflict resolution, decision making, leadership and teambuilding, management of contractors and vendors.