Sr. Validation Engineer II

Role Summary

This role supports operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. It is accountable for performing activities such as Cycle Development, Design Qualification, Commissioning and Qualification, Performance Qualification and Cleaning Validation, and Validation Maintenance, with a focus on right-first-time execution and continuous improvement.

Responsibilities

• 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 such as impact to predetermined timelines and problems as needed.
• Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, computerized systems, utilities, facility, and computerized systems.
• 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 approval of commissioning documents, including but not limited to commissioning protocols and reports.
• Evaluate and leverage testing to qualification activities.
• Generate, execute, and manage the detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation.
• Support departmental and capital project validation activities.
• Provide validation key performance indicators data in a predetermined frequency.
• Owner of change control task of validation activities.
• Execute validation activities aimed at improving Right First-Time.
• Ensure new systems are implemented within predetermined timelines and financial forecasts.
• Present and provide rationale for the completed work during periodic audits and Health Authority inspections.
• Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols.
• Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines.
• Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
• Solve technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.
• 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 as described in Takeda Standards, policies, and procedures.
• May perform other duties as assigned.

Qualifications

• Required: BS engineering with a minimum of 10+ years’ experience in validation.
• Required: Advanced knowledge of equipment, computerized systems, facilities, and utilities in a regulated environment; advanced knowledge of commissioning and qualification of equipment, computerized systems, facility, and utilities.
• Required: Ability to independently evaluate technical situations and propose potential solutions; ability to work independently or in teams, partners, suppliers, and customers; strong communication skills in verbal and written form.
• Preferred: Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers.
• Preferred: Knowledge of cGMPs or equivalent regulations, validation-related regulations, guidelines, and best practices.
• Preferred: Basic understanding of data and statistical analysis of validation test results.
• Preferred: Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance.
• Preferred: Proficiency in Microsoft Word and Excel.

Skills

• Strong problem-solving mindset with technical and/or engineering knowledge.
• Collaborative ability to work with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
• Effective written and verbal communication, including technical/business writing.
• Ability to generate and manage detailed project plans and documentation.
• Capability to troubleshoot and resolve validation issues through cross-functional partnerships.

Education

• BS in Engineering (as specified in Qualifications)

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; may require respiratory protection around certain chemicals.
• Work in a cold, wet environment and may involve weekends or supplemental hours; on-site presence 80% or more at Thousand Oaks site.
• Must be able to work more than 8 hours a day or 40 hours per week as required; may require availability outside regular business hours.