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 by qualifying and maintaining equipment systems in a qualified/validated state according to established policies and procedures.

• Develop and execute validation/qualification deliverables (Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports).
• Ensure periodic reviews and requalification are performed per schedule.
• Support equipment qualification and validation activities.
• Develop qualification protocols and associated reports while adhering to change management.
• Author and review SOPs, WPs, test protocols, and validation deliverables/plans/policies as needed.
• Perform validation lifecycle maintenance (validation document hierarchy, tracking execution work from change controls, shutdown/changeover validation management, and management of revalidation and cleaning monitoring programs if necessary).
• Execute work from change strategy, risk assessment, testing, and compliance gaps.
• Execute a portfolio of limited-scope and complex validation projects under strict deadlines.
• Maintain familiarity with qualification/validation directives and industry guidelines.

• Review, prioritize, and promptly respond to end-user equipment qualification and support requests.
• Provide technical support and guidance; interface with customers to meet expectations.
• Maintain positive relationships and contribute to multi-function teams representing validation.

• Align with validation and quality engineering directives/guidelines.
• Serve as SME in internal and regulatory audits as needed.
• Contribute to regulatory inspection readiness.
• Perform other duties as assigned.

• Familiarity with cGMP in the pharmaceutical industry.
• Preferred: direct experience with equipment, facility, sterilization commissioning/qualification, critical utilities validation, temperature mapping.
• Suggested: distributed control systems and automation (GAMP) validation concepts.
• Knowledge required to design/implement quality systems and validation program elements for automated multi-product biologics/cell therapy manufacturing.
• Familiarity with regulatory validation requirements (FDA, EMA, ICH Q7/Q8/Q9) particularly for biologics/cell therapy.
• Preferred: lean principles and six sigma.
• Proficiency in project management, communication, and technical writing.
• Ability to handle multiple priorities, solve complex/unusual problems, and work independently.
• Working knowledge of SOPs, cGMPs, compliance requirements, and regulatory guidelines (FDA/EU); demonstrated via previous site-level validation philosophy/regulation projects.
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.

• Required:
  
  BS in Chemical Engineering, Mechanical Engineering, related discipline (or equivalent).
• Required:
  
  3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and lab instrumentation in an FDA-regulated manufacturing facility.
• Required:
  
  2+ years’ experience in equipment, facility, or utility qualification.

• Compensation range (Devens, MA): US $92,540–$112,136 (additional incentive cash/stock may be available).
• Health Coverage (medical, pharmacy, dental, vision), wellbeing programs, and financial protection (401(k), disability, life insurance, etc.).
• Paid Time Off (including flexible time off/paid holidays; additional eligibility-based time off such as paid sick time, volunteer days, summer hours, leaves of absence, and annual Global Shutdown).