Senior Specialist, Validation Engineer II

Principal Objective of the Position

The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent qualifies new equipment, facilities, and utilities and maintains equipment systems in a qualified/validated state according to established policies and procedures.

Major Duties and Responsibilities

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, and Summary Reports
• Ensures periodic reviews and requalification are performed in accordance with schedule
• Supports equipment qualification and validation activities
• Develops qualification protocols and associated reports while adhering to a change management process
• Authors and reviews SOPs, WPs, test protocols, validation deliverables, plans, and policies
• Executes validation lifecycle maintenance including validation document hierarchy, tracking execution work from change controls, shutdown/changeover management, and management of revalidation and cleaning monitoring programs
• Executes work arising from change strategy, risk assessment, testing, and compliance gaps
• Executes a portfolio of limited scope and complex validation projects under strict deadlines
• Maintains familiarity with BMS directives and industry guidelines on qualification/validation
• Provides technical support and guidance on qualification and validation issues
• Interfaces with customers to ensure expectations are met
• Contributes to multi-function teams, representing validation
• May be called upon as SME in internal and regulatory audits
• Contributes to preparation for regulatory inspection readiness

Knowledge and Skills

• Familiarity with cGMP in the pharmaceutical industry
• Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred
• Knowledge of distributed control systems and automation (GAMP) validation concepts suggested
• Knowledge in designing and implementing quality systems and validation program elements for a fully automated, multi-product, biologics/cell therapy manufacturing facility
• Familiarity with regulatory validation requirements including FDA, EMA, and other worldwide requirements (ICH Q7, Q8, Q9)
• Working understanding of lean principles and six sigma process is preferred
• Demonstrated proficiency in project management, communication, and technical writing skills suggested
• Strong interpersonal and communication skills; team player with initiative, accountability, and professional maturity
• Strong problem-solving, verbal and written communication skills, and ability to work independently
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry

Qualifications

• Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or equivalent is required
• Minimum of 3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in an FDA regulated manufacturing facility
• Minimum of 2+ years experience in equipment, facility, or utility qualification