Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience Bachelor in Science, Engineering, Chemistry, Biology.
Use of validation equipment and instrumentation
Quality systems (Change Control, CAPA, Deviations) management and ownership
Technical writing skills
Project management experience
Temperature chambers knowledge (operation, validation, maintenance)
MS Office suite
Excellent organization and communication skills
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. 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 novel 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
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 organization 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 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.
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 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
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.
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:
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
Project cost development
Leadership and teambuilding
Management of contractors and vendors