Summary - Responsible for technical support and execution of Process Validation and equipment qualifications following Validation Program at a facility.
Essential Duties: Provides technical and project leadership over Vision System Integration and/or Manufacturing Equipment Modification validation in support of company projects, support of manufacturing operations and for eventual release testing of intermediate and finished products. Develop test method qualification and validation protocols for Vision System Integration and/or Manufacturing Equipment Modifications. Ensure validation master plans comply with Client and regulatory agency requirements. Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines. Support continuous improvement within the validation department. Support regulatory submissions and regulatory agency inspections as required Represent Client validation department to industry as required. May perform other duties as assigned.
Qualifications Required skills include: Ability to work effectively with multi-department and multi-site teams. Ability to manage and organize complex technical problems. Good written and oral communication skills, excellent attention to details. Strong team leader with project management skills and focus on results.
Education and Experience Minimum of BA or BS (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 2+ years related experience or demonstrated performance within a GMP regulated environment within the pharmaceutical industry.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity. Must display eagerness to learn and continuously improve. Must have uncompromising dedication to quality. Must have relentless focus on rapid and disciplined action. Must have respect for individuals and the diverse contributions of all.
Work Environment. Normal office environment. May be required to travel for business reasons, e.g. training and meetings. May be around moving equipment and machinery. May be working in a loud area that requires hearing protection and other protective equipment to be worn. Must be able to work more than 8 hours a day or 40 hours a workweek (any shift) as required. Will have interaction with other people. Pace may be fast and job completion demands may be high. The overall physical exertion of this position is sedentary work. May be required to lift up to 15 pounds. Working with computer.