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Quality Validation Engineer

Location
Elgin, Illinois
Posted
21 Sep 2022

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Job Description

About the role:

The Quality Validation Engineer, reports to the Quality Validation Manager. You will work with 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. Focus areas typically include n disciplines related to equipment, cleaning, process, control system and computer system validations.

How you will contribute:

  • Own and Approve Standard Operating Procedures and other Quality system Documentations

  • Approve, develop and deliver training materials

  • Validate Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance to existing requirements.

  • Lead teams in the execution of risk management activities.

  • Owns investigations and CAPAs relevant to area of responsibility/expertise.

  • Approves change controls for compliance to existing requirements.

  • Lead quality project teams and present to Plant management project plans, progress, and risks.

  • Represent the organization in areas of expertise to governmental Regulatory bodies.

Minimum Requirements/Qualifications:

  • Typically requires bachelor's degree in the Sciences/Engineering/Chemistry or other job-related technical field.

  • 2+ years related work experience in validation within a pharmaceutical, biotech or related industry.

  • Must be able to influence decisions based on regulatory knowledge.

  • Experience in the application of cGMPs. Knowledge of validation principles across multiple disciplines.

  • Ability to solve complex validation issues.

  • Must demonstrate excellent problem solving and critical thinking skills and understanding of complex manufacturing processes.

  • Experience presenting to inspection auditors a plus.

  • Strong knowledge of descriptive statistics.

  • Working knowledge of inferential statistics and related techniques (e.g., sample size determination, comparative analysis, ANOVA, DoE).

  • Proactively identifies, escalates, and/or resolves potential compliance and/or safety issues

  • In general, the position requires a combination of sedentary work and walking around the facility.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous paid time off for vacation, sick leave, and volunteering

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Professional development and training opportunities

  • Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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 - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 717484934-2
  • Date Posted: 21 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Elgin, Illinois
  • Salary: On Application