Senior Validation Engineer

Senior Validation Engineer

Company: Takeda

Location: USA – CA – Thousand Oaks – Rancho Conejo

Job Type: Full time, Employee, Regular

Salary Range: $86,500 – $135,960

As a Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. You will be responsible for performing activities such as Cycle Development, Design Qualification, Commissioning and Qualification, Performance Qualification, Cleaning Validation, and Validation Maintenance. The focus is on right first‑time execution and continuous improvement. You will report to the Head of Engineering Services and will work on site five days a week.

• Be a Validation Engineering representative and technical subject‑matter expert (SME) on cross‑functional and multi‑site teams related to equipment, systems, utilities, facilities, and computerized systems as applicable to its assigned role.
• Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans.
• Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its assigned role.
• 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 inter‑departmental and cross‑functional partnerships.
• Maintain a state of inspection readiness and act as SME in Health Authority inspections.
• Approve commissioning documents, including but not limited to commissioning protocols and reports.
• Evaluate and leverage testing for qualification activities.
• Generate, execute, and manage detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change‑management activities, and associated documentation.
• Support departmental and capital project validation activities.
• Provide key performance indicator data on a predetermined frequency.
• Own change‑control tasks 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 and perform tactical activities, including sample collection, coordination with cross‑functional support teams, data and result retrieval, and documentation completion as required by protocols.
• Coordinate and perform equipment and system re‑qualification according to procedures and predetermined timelines.
• Foster an environment that encourages continuous learning and maintain expertise to stay abreast of technical and industry advancements.
• Support EHS programs and own CAPA records as needed.
• Be accountable for behaviors as described in Takeda standards, policies, and procedures.

• BS engineering with 8+ years of experience in validation.
• Experience with systems such as LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer‑systems validation.
• Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment, including commissioning and qualification of equipment, systems, computerized systems, facilities, and utilities.
• Familiarity with software development lifecycle (SDLC) and validation tools.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
• Strong technical and engineering knowledge and ability to collaborate with Process Engineering, Quality, Project Management, Facilities, Automation, and other groups.
• Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations and industry guidance.
• Advanced understanding of data and statistical analysis of validation test results.
• Basic understanding of data and statistical analysis of validation test results.
• Knowledge of cGMPs or equivalent regulations, validation‑associated regulations, guidelines, and best practices.
• Proficient in Microsoft Word, Excel, and computer software.

• Work in a controlled environment requiring special gowning and protective clothing for head, face, hands, feet, and…