Lead Validation Engineer

Looking for a Lead Validation Engineer to join a team responsible for establishing and implementing the validation strategy for a given sector of validation (i.e. equipment, facilities, utilities, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. Will provide guidance to operational teams for managing projects as well as lead or co-lead projects, and manage time to meet objectives. Forecast and plan resource requirements (people, financial and technology) for projects across the division. Plan and coordinate validation/qualification work assigned including validation plans, validation strategy, requirements specifications, qualification protocols and impact/risk assessments. Review and approve change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state. Work with operations, quality, technical groups and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes. Ensure the validated state of equipment, instruments and systems supporting manufacturing is compliant with corporate policies and regulatory requirements. Provide technical support and participate in the implementation of change controls and commitment action items. Prepare material for and deliver validation training on validation topics including training on guidance/best practices or site-specific requests for validation workshop training. Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations. Review and approve investigations, commitments and procedures and maintenance work orders as they relate to validation. Skills needed- Word, Excel, Computerized Systems