Senior Validation Manager (Biotech / Pharmaceutical industry)

Manage and oversee a group of engineers responsible for executing equipment, facility and utility validation at a commercial/clinical biologics-manufacturing site. Set group goals, drive for progress, create execution strategies, train and develop internal talent and assess performance against goals. Write validation plans, protocols and summary reports using provided templates. Collect and review validation data and dispositions tests. Review and approve protocols executed by others for compliance with validation policies and procedures. Participate on the validation review board and support creation of the site validation master plan. Represent the validation engineering group on quality system initiative teams. Provide input towards the development of validation SOP?s and templates. Support regulatory submissions and internal or external audits. Integrate corporate policies, business needs and regulatory requirements into project execution. Implement lean engineering concepts. Provide technical and troubleshooting support to project teams. Interact with leaders from other sites, disciplines and senior management. This position is part of an engineering job family. The job grade will be commensurate with experience. BS or MS in engineering or science. 10+ years of post-graduate relevant experience in biologics or pharmaceutical validation and 2+ years of validation program/group management is also required. Knowledge of current industry standards and regulatory trends as they pertain to validation engineering is necessary. Candidate must have significant experience in establishing programs for and executing cleaning validation, steam sterilization validation, clean utility validation, revalidation and regulatory auditing. Candidate must be results-oriented, able to make decisions and able to prioritize work per business needs. Strong leadership, coaching, communication, organization and time management skills are necessary.