Quality Validation Engineer II

BioSpace; Libertyville (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Takeda seeks a Quality Validation Engineer II for their Round Lake facility, ensuring quality standards in pharmaceutical processes. The role includes auditing, compliance management, and collaboration across teams to uphold safety and efficacy in drug validation, requiring a BS in a related field and relevant experience.

Benefits

Medical, dental, vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid volunteer time off

120 hours of paid vacation per year

Short-term and long-term disability coverage

Qualifications

• 2+ years related validation experience in pharmaceutical/biotech.
• Experience in qualifying laboratory equipment and method validation.
• Ability to lead cross-functional teams and present to management.

Responsibilities

• Define and audit quality processes to meet regulatory standards.
• Manage Quality System Documentation and deliver training materials.
• Lead and participate in risk management and validation plans.

Skills

cGMPs

Problem-solving

Microsoft Office

Descriptive statistics

Inferential statistics

Education

BA or BS in Sciences/Engineering/Chemistry

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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Pay found in job post

Retrieved from the description.

Base pay range

$70,000.00/yr - $110,000.00/yr

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

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

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 - IL - Round Lake Innovation Park

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

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