Senior Validation Engineer

Role Summary

Senior Validation Engineer responsible for the qualification and validation maintenance of equipment, systems, facilities, and utilities, including Cycle Development (CD), Design Qualification (DQ), Commissioning and Qualification (C&Q), Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. This is an on-site role based in Thousand Oaks, CA.

Responsibilities

• Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the 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 the 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 interdepartmental 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 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 key performance indicators data in a predetermined frequency.
• Own change control task of validation activities.
• Execute validation activities aimed at improving Right First-Time.
• 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.
• Support EHS programs and own CAPA records as needed.
• Accountable for behaviors as described in Takeda Standards, policies, and procedures.

Qualifications

• Required: BS engineering with 8+ years' experience in validation.
• Required: Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers.
• Required: Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment; advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities.
• Required: Familiarity with software development lifecycle (SDLC) and validation tools.
• Required: Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
• Required: Strong technical/engineering knowledge with ability to work collaboratively with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
• Required: Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, and guidance.
• Required: Advanced understanding of data and statistical analysis of validation test results; basic understanding also noted.
• Required: Knowledge of cGMPs or equivalent regulations, validation-related regulations, guidelines, and best practices.
• Required: Proficiency in Microsoft Word and Excel (computer software).

Skills

• Validation documentation and protocol development
• Cross-functional collaboration and stakeholder management
• Data analysis and interpretation of validation results
• Regulatory compliance and inspection readiness
• Project planning and change management
• Technical writing and communication

Education

• BS in Engineering or equivalent technical degree

Additional Requirements

• Work in a controlled environment requiring gowning and personal protective equipment; potential exposure to chemicals and loud areas.
• May require working multiple shifts, weekends, or supplemental hours; may involve availability outside regular business hours.
• Potential for travel or relocation not specified; work location is on-site in Thousand Oaks, CA.
• Ability to work in clean room environments and wear required protective clothing.