Senior Manager Validation Engineering

Role Summary

Senior Manager Validation Engineering located in Devens, MA. Lead validation engineering activities for qualification of facility, utilities, and processing equipment, and oversee installation, operational, and performance qualification of systems arising from projects and change controls. Drive site validation programs, project plans, and a high-performance team to support patient-centric manufacturing and regulatory compliance.

Responsibilities

• Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems.
• Lead installation, operational and performance qualification (I/O/PQ) activities for systems arising from projects and change controls.
• Lead the site Periodic Assessment and Requalification program; establish procedures aligned with directives and industry guidance; ensure execution to schedule.
• Establish validation project plans commensurate with risk; manage execution of validation projects with coordination among customers, collaborators, and quality.
• Oversee validation execution work from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation; align plans with Validation Management and Quality Assurance.
• Deliver validation projects under tight deadlines including plans, protocols, test scripts, risk assessments, and summary reports.
• Manage multiple projects and serve as a primary contact for validation execution projects.
• Act as validation SME; present philosophies and strategies to inspectors and auditors.
• Collaborate with Engineering, Digital Plant, Manufacturing and Quality.
• Manage resources to address priorities, meet schedules, reduce costs, and increase efficiencies.
• Ensure alignment with directives and industry guidelines on validation.
• Develop and lead a high-performance team; recruit, develop leadership, coach, mentor, and administer rewards.
• Establish high performance standards, accountability, and continuous improvement to reduce variances and cycle time.

Qualifications

• BS in engineering or scientific/technical discipline; relevant industry experience.
• Minimum of 6 years in 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.
• Previous managerial experience preferred (staff selection, motivation, financial resource management).
• Experience presenting validation philosophies to BOH Inspectors, External/Internal Auditors.
• Familiarity with distributed control systems and automation (GAMP) validation concepts.
• Lean principles understanding; excellent project management, communication, and technical writing skills.
• Ability to represent the department to customers, regulatory agencies, and management with professionalism and technical competency.
• Understanding of engineering documentation (P&IDs, Process Flow diagrams, SOPs).
• Knowledge of regulatory validation requirements (FDA, EMA, ICH Q7/Q8/Q9) as applied to biologics manufacturing.
• Proven ability to work in a matrix environment and lead cross-functional teams to meet objectives.

Skills

• Project management
• Technical writing
• Cross-functional collaboration
• Regulatory compliance and auditing
• Validation strategy and execution

Education

• B.S. in engineering, scientific or technical discipline (or equivalent).