Sr. Validation Engineer II

About the Role

This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first‑time execution and continuous improvement.

• Lead the execution of CD/PQ/CV/PV/RV activities.
• Act as project manager for validation deliverables, ensuring new systems are implemented within predetermined timelines and financial forecasts.
• Supervise and manage contractors or consultants as needed.
• Participate in change control review board.
• Track and trend activities and report on issues that impact predetermined timelines.
• Serve as the Validation Engineering representative and technical SME on cross‑functional and multi‑site teams related to equipment, computerized systems, utilities, and facilities.
• Apply advanced theory, technical principles and expert judgment to address a broad range of problems.
• Troubleshoot and direct the resolution of validation issues by fostering effective interdepartmental and cross‑functional partnerships.
• Maintain a state of inspection readiness and act as SME in Health Authority inspections.
• Review and approve commissioning documents, including protocols and reports.
• Evaluate and leverage testing for qualification activities.
• Generate, execute, and manage detailed project plans and timelines for CD/DQ/IQ/OQ/PQ/CV/validation maintenance, change management activities and their documentation.
• Support departmental and capital project validation activities.
• Provide validation key performance indicator data in a predetermined frequency.
• Own the change control task of validation activities.
• Execute validation activities aimed at improving Right First‑Time.
• Present and provide rationale for completed work during periodic audits and Health Authority inspections.
• Coordinate tactical activities such as sample collection, data retrieval, documentation completion per protocols.
• Coordinate equipment and system re‑qualification according to procedures and predetermined timelines.
• Foster an environment that encourages continuous learning.
• Maintain expertise to stay abreast of technical and industry advancements.
• Solve technical problems while maintaining required safety, quality, and production standards.
• Support EHS programs and own CAPA records as needed.
• Manage time effectively, prioritize tasks, set goals, and develop systems for achieving those goals.
• Accountable for behaviors described in Takeda Standards, policies, and procedures.
• May perform other duties as assigned.

• BS in engineering with a minimum of 10+ years’ experience in validation.
• Experience with LIMS, MES, ERP, SCADA, or DCS (e.g., DeltaV) for computer‑system validation is desirable.
• Advanced knowledge of equipment, computerized systems, facilities, and utilities in a regulated environment.
• Advanced knowledge of commissioning and qualification of equipment and computerized systems.
• Problem‑solving mindset with strong technical and/or engineering knowledge and strong collaborative skills with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
• Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance.
• Basic understanding of data and statistical analysis of validation test results.
• Knowledge of cGMPs (or equivalent regulations), validation associated regulations, guidelines, and best practices.
• Ability to independently evaluate technical situations and propose potential solutions.
• Ability to work independently or in teams, partners, suppliers, and customers.
• Ability to communicate effectively at all levels verbally and in written form, including technical/business writing.
• Proficiency in Microsoft Word and Excel.

Work in a controlled environment requiring special gowning and protective clothing over the head, face, hands, feet and body.…