Senior Manager Validation Engineering

Role Summary

Senior Manager Validation Engineering based in Devens, MA. Leads validation engineering activities for the qualification lifecycle of facility, utility and processing equipment systems, including installation, operational and performance qualification (I/O/PQ), site periodic assessment and requalification, and execution of validation projects and programs. Serves as a validation SME and primary contact for inspectors and auditors, collaborating with Engineering, Digital Plant, Manufacturing and Quality to drive continuous improvement and efficiency.

Responsibilities

• Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems.
• Lead functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls.
• Lead the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensure 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.
• Oversee validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs; coordinate with Validation Management peers, Validation Program management and Quality Assurance.
• Deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, including plans, protocols, test scripts, risk assessments, and summary reports.
• Manage multiple projects while serving as a point of contact for validation execution projects.
• Act as a validation SME, presenting validation philosophies and strategies to Board Of Health inspectors and auditors.
• Collaborate with Engineering, Digital Plant, Manufacturing and Quality; effectively manage 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 validation execution; manage recruitment and development of staff and leadership through development opportunities, coaching, mentoring, and rewards/recognition.
• Establish and communicate high performance standards, clear accountability, and lead continuous improvement to reduce variances and cycle time.

Qualifications

• Knowledge of Engineering and Quality Assurance generally attained through a B.S. in engineering or a related discipline, or equivalent experience.
• Minimum B.S. in a scientific, technical or engineering discipline.
• Minimum 6 years of 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 with personnel selection, motivation and retention, and financial resource planning preferred.
• Experience presenting validation philosophies, strategies and testing to Board of Health inspectors, external auditors, and internal stakeholders.
• Familiarity with distributed control systems and automation (GAMP) validation concepts for cross-functional validation efforts.
• Lean principles understanding preferred; excellent project management, communication, and technical writing skills required.
• Professionalism and technical competency to represent the department to customers, regulatory agencies, and management.
• Demonstrated ability with engineering documentation such as P&IDs, Process Flow diagrams, and Standard Operating Procedures.
• Knowledge of regulatory validation requirements including FDA, EMA and other worldwide regulations (ICH Q7, Q8, Q9) as applied to biologics manufacturing.
• Proven ability to lead multi-level / cross-functional teams in a matrix environment to achieve site and departmental objectives.

Skills

• Project management
• Technical writing
• Validation governance and compliance
• Cross-functional collaboration
• Regulatory inspection readiness
• People leadership and development

Education

• B.S. in engineering or a scientific/technical discipline (or equivalent experience).