Senior Quality Validation Engineer

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This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Compensation and Location

U.S. Base Salary Range : $86,500.00 - $135,960.00

Location : USA - IL - Round Lake Innovation Park

About The Role

The Senior Quality Validation Engineer is in the Validation Quality organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. You will work as part of teams providing quality oversight and approval of change control and validation deliverables to ensure that products and processes meet regulatory validation requirements, internal company standards and current industry practices. This role typically focuses on disciplines related to equipment, cleaning, process, control system and computer system validations. You will report to the Quality Validation Manager.

How you will contribute

• Quality Systems / Document Control : Owns Standard Operating Procedures and other Quality System Documentation relevant to their area of expertise. Approve SOPs and other Quality System Documentation relevant to all areas of the plant.
• Training : Develops and delivers training materials relevant to area of expertise. Approve training materials relevant to all areas of the plant.
• Validation Quality : Participates as a team member in the execution and documentation of Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages following existing procedures. Review deliverables for compliance to existing requirements. Approve validation documentation (e.g., protocols, CWRs, or risk assessments) that establishes novel requirements or assesses risk.
• Risk Management : Leads teams in the execution of risk management activities.
• Deviations and CAPA : Owns investigations and CAPAs relevant to responsibilities / expertise. Approve investigations and CAPAs relevant to all areas of the plant.
• Change Control : Approves change controls for compliance with existing requirements.
• Quality Leadership : Leads Quality project teams and presents to Plant management project plans, progress, and risks. Represents the function in areas of expertise to governmental Regulatory bodies.
• Complete assigned training.
• Identifies, escalates, and / or resolves potential compliance and / or safety issues.

What you bring to Takeda

Important Considerations

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.

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.

Job Function & Seniority

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