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Job Description

About the role:

As Senior Validation Engineer, you will support 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. You will report to Head of Engineering Services.

How you will contribute:

• 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.

What you bring to Takeda:

• 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.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• The overall physical exertion of this position is light work.
• Able to work in controlled or clean room environments requiring special gowning.
• May be required to work or be assigned to a different shift as needed.
• May require availability outside regular business hours.
• Pace may be fast and job completion demands may be high.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - CA - Thousand Oaks - Rancho Conejo

U.S. Base Salary Range:

$86,500.00 - $135,960.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes