Doctorate degree in Sciences/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience.
Must have experience on Aseptic Validation Processes on aseptic controlled environments. Meaning, Media Fill, Smoke Profile and/or Environmental Performance Qualification. Protocol and Report preparation. Experience on assessment preparation for Change Control and investigations.
Manages and/or applies extensive technical validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of processes, systems or facilities. Establish validation engineering policies for a major segment of the company. Interpret, execute, and/or recommend modifications to company-wide policies. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity. Plan, organize and coordinate work of a staff of engineers and/or technicians. Lead efforts 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. Prompt and regular attendance to workplace. * Other functions may be assigned. Expert validation knowledge (equipment qualification, cleaning, sterilization). Is recognized as a leader and authority in company in broad area of specialization or intensely specialized field. Global/Multi Site Lead for large or complex or business critical project). Provide technical validation solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Works under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results. Develops advanced technological ideas and guides their development into a final product. Has full responsibility for interpreting, organizing executing and coordinating assignments. Supervision received is essentially administrative, with assignments given in broad terms concerning general objectives and limitations. Essential to the completion of corporate wide initiatives and programs.
Decisions, recommendations and actions form the basis of corporate program schedules and personnel/fiscal resource utilization and affect the image of the organization’s technological capability. Leads efforts of organization within functional boundaries, influences efforts of adjacent organizations. Expected to be capable of managing complex project objectives or multi-tiered organization. May be expected to directly supervise staff or project resources. Serves as organization spokesperson on advanced projects and/or programs. Acts as advisor to management and customers on advanced validation engineering studies and applications. Acts as a technical liaison to individuals within and outside the organization with responsibility to act independently regarding technical matters in individual’s field. Comprehensive understanding of regulatory requirements and applications. Key expert and decision maker for validation compliance issues.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS Knowledge of theories and principles related to leading edge technologies. Advanced technical expert in at least one specialty area. (Corporate level). Ability to motivate and communicate vision/direction of validation program. Ability to influence validation program at a site/corporate level. Demonstrated Skills in the following areas: Advanced project management, Presentations to large groups, External networking, Personnel coaching and development, 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.