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Job Description

The Quality Validation Engineer II ensures the quality of processes and product outputs. You will define activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting on deviations and defects. By maintaining high standards, you will support Takeda's mission to deliver quality products. You will report to the Quality Validation Manager.

About the role:

The Quality Validation Engineer II position is in the Validation Quality organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. You will work as part of cross-functional teams providing quality oversight and approval of change control and validation deliverables to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. You will typically focus on disciplines related to equipment, cleaning, process, control system and computer system validation.

How you will contribute:

• Experience applying cGMPs. Knowledge of validation principles across multiple disciplines.
• Will work as a collaborative team member and, in some cases, lead a small team to resolve small to medium scope validation issues.
• Must demonstrate excellent problem-solving and understanding of complex manufacturing processes.
• Experience presenting to inspection auditors.
• Microsoft Office (Word, Excel, PowerPoint) skills. Knowledge of descriptive statistics.
• Working knowledge of inferential statistics and related techniques (e.g., sample size determination, comparative analysis, ANOVA, DoE).
• Complete assigned training.
• Identify, escalate, and resolve potential compliance and safety issues.

What you bring to Takeda:

• Requires a BA or BS in the Sciences/Engineering/Chemistry or other job-related discipline.
• 2+ years of related experience in validation within a pharmaceutical, biotech, or related industry.
• Manage Standard Operating Procedures and other Quality System Documentation relevant to their area of expertise, and will approve Standard Operating Procedures and other Quality System Documentation important to all plant areas.
• Develop and deliver training materials relevant to their area of expertise and will approve training materials important to all areas of the plant.
• Participate 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, Computerized System Change Orders, Controlled System Work Requests.
• Approve deliverables for compliance to defined requirements.
• Experience in qualifying analytical laboratory equipment and performing method validation
• Lead cross-functional teams in the execution of risk management activities.
• Approve change controls for compliance to defined requirements.
• Lead Quality project teams and present to Plant management project plans, progress, and risks. Will represent us in areas of expertise to governmental Regulatory bodies.

Important Considerations

• Must be able to lift, push, pull 25 lbs and carry up to 50 lbs.
• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.
• Can work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a loud area that requires hearing protection and other protective equipment to be worn.
• 20/20 near vision required (corrected vision is acceptable).
• Will work in a cold, wet environment.
• Will work around chemicals such as alcohol, acids, and alkalines that require protective equipment.
• May work in a confined area. Inside and Outdoor working conditions.
• Some Clean Room and cool/hot storage conditions.
• Perform removal of hazardous waste.

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.

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 - IL - Round Lake Innovation Park

U.S. Base Salary Range:

$70,000.00 - $110,000.00

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 - IL - Round Lake Innovation Park

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes