Takeda · 1 day ago
Senior Validation Engineer
Thousand Oaks, CA
Full-time
Onsite
Senior Level, Lead/Staff
$86K/yr - $136K/yr
8+ years expTakeda is a company transforming patient care through the development of novel specialty pharmaceuticals. In this role, the Senior Validation Engineer will support operations by ensuring the qualification and validation maintenance of equipment, systems, and utilities, while fostering continuous improvement and right first-time execution.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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 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 interdepartmental and cross-functional partnerships
Maintain a state of inspection readiness and act as SME in Health Authority inspections
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 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
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
Qualification
Required
BS engineering with 8+ years' experience in validation
Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers
Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment is required
Advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities is required
Familiarity with software development lifecycle (SDLC) and validation tools
Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks
A strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups
Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, 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 and Excel, computer software
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
Pharmaceutical Technology
2026-01-11
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