Lead the Technical Services Validation group responsible for implementing and maintaining a robust validation lifecycle for process automation systems, manufacturing execution system recipes and computer systems. Supports validation for process equipment, SIP/CIP processes, critical process equipment & utility systems and laboratory instrumentation.
Maintain validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics commercial manufacturing facility and clinical manufacturing facility.
Responsibilities include oversight of validation lifecycle maintenance that includes establishment of validation document hierarchy, changeover management related to validation, and management of the revalidation/periodic assessment and cleaning monitoring programs.
This individual works in conjunction with Validation Management, Digital Plant, Manufacturing, Manufacturing Engineering and Quality Assurance to manage program and strategies aligned with site validation philosophies.
Responsible to deliver regulatory inspection readiness training, coaching and guidance to junior level staff and subject matter experts (SME) to ensure validation philosophies are well understood and represented to regulators.
Manage multiple projects while serving as a point of contact for validation program elements.
Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Board Of Health (BOH) inspectors and auditors..
Effectively manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on validation.
Develop and lead a high performance team responsible for the validation lifecycle program, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.
Establish and communicate high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time.
Develop annual operating budget/staffing levels and manages operation to achieve them.
Knowledge and Skill
Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in scientific, engineering, or technical discipline, or its equivalent and applicable industry experience.
A minimum of 8 years experience (or equivalent) directly relevant experience in validation and/or engineering of process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in a biologics manufacturing facility.
Proven experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics manufacturing facility.
Extensive knowledge in establishing site and program validation strategies that are aligned with current industry mindsets.
Direct experience with Board of Health (BOH) Inspectors, External Auditors. Corporate and Internal Auditors presenting validation philosophies, strategies and executed testing.
Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a superior team is desirable.
A working understanding of lean principles and establishment of effective process metrics is preferred.