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Position: Senior Manager Validation Engineering

Location: Devens, MA

Key Responsibilities:

• Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems.
• Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls.
• Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule.
• Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.
• Responsibilities include oversight of validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs. This individual works in conjunction with Validation Management peers, Validation Program management and Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies.
• Responsible to deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, this includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.
• Manage multiple projects while serving as a point of contact for validation execution projects.
• 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.
• Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality.
• Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Ensure alignment with BMS directives and industry guidelines on validation.
• Develops and leads a high-performance team responsible for validation execution, 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.
• Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time
   

Qualifications & Experience:

• Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
• This position requires a B.S. degree in a scientific, technical or engineering discipline.
• A minimum of 6 years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in a biologics manufacturing facility.
• Direct experience with equipment, facility, sterilization qualification, critical utilities validation, and temperature mapping concepts is required.
• Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources preferred.
• Experience with Board of Health (BOH) Inspectors, External Auditors, Corporate and