Validation Engineer

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Position Title: Validation Engineer

Position Location: Thousand Oaks, CA

About the role:

As a 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 the Head of Engineering Services.

How you will contribute:

• Create and implement the detailed project plans and timelines for implementing CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation.

• Support departmental and capital project validation activities.
• Provide validation measurements data in a predetermined frequency.
• Owner of change control task of validation activities.
• Build 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 support teams, retrieving data and results, completing documentation per protocols.
• Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines.
• Foster an environment that encourages learning. Maintain expertise to stay informed about 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.
• Accountable for behaviors as described in Takeda Standards and procedures.

What you bring to Takeda:

• BS engineering with 1+ years' experience in validation.

• Experience in the pharma/biotech industry is required.

• Experience in the pharma/biotech industry is required.
• Knowledge of cGMPs or equivalent regulations.
• Basic knowledge of equipment, systems, facilities, and utilities in a regulated environment is required.
• 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. You may:

• The physical exertion of this position is light work.
• Pace may be fast and job completion demands may be high.
• 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.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• May work or be assigned to a different shift.
• Will work more than 8 hours a day or 40 hours a workweek.
• May require availability outside regular business hours.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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-1

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:

$56,000.00 - $88,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time