Sr. Validation Scientist SUMMARY 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. FUNCTIONS - Able to troubleshoot systemic validation issues. - Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. - Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. - Complete complex or Client assignments requiring development of new and/or improved validation engineering techniques and procedures. - Develop validation engineering policies and procedures that affect multiple organizational units. - Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. - Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. - Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. - Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. - Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. - Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. - Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. - Prompt and regular attendance to the workplace. *Other functions may be assigned Knowledge: - Advanced validation knowledge (equipment qualification, cleaning, sterilization). - Applies extensive technical validation expertise, and has full knowledge of other related disciplines. Problem Solving: - Provide technical solutions to a wide range of difficult problems. - Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Discretion/Latitude: - 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. Impact: - 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. Leadership: - Leads efforts of group of peers 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. Liaison: - 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. Regulatory: - Understands regulatory trends in industry and 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/LICENSES - Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. COMPETENCIES/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.