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Validation Specialist
2 months ago
We are seeking a highly skilled Validation Specialist to join our team at Takeda Pharmaceutical. As a key member of our Engineering Validation team, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities:- Design, Author, and Execute commissioning, qualification, and validation studies for various disciplines, including facilities, utilities, and equipment, as well as computerized systems and process validation.
- Partner with Subject Matter Experts to ensure efficient execution of testing strategies and provide technical support for change controls, investigations, deviations, and CAPAs.
- Conduct Risk and Impact Assessments to identify potential risks and develop mitigation strategies.
- Develop and Maintain Standard Operating Procedures and validation assessments to ensure compliance with regulatory requirements.
- Collaborate with Customers to resolve technical issues and provide validation support.
- Participate in Audits and Regulatory Agency Inspections as a representative of the Engineering Validation team.
- Develop and Implement Best Demonstrated Validation Practices within the validation department, based on current industry practices and guidelines.
- Support Operations and Communications with Program Managers and other stakeholders.
- Bachelor's Degree in Engineering Discipline preferred.
- Minimum 5 Years Validation Experience for this non-manager role.
- Minimum 7 Years of Relevant Experience in a GMP regulated environment.
- At Least 4 Years of Commissioning, Qualification, and Validation (CQV) Experience desired.
- Strong Knowledge of Industry Guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
- Proficient with Microsoft Office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
- Validation and System Experience in various areas, including sterilization and aseptic processing validation, cleaning validation of manufacturing equipment, process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
We offer a competitive salary range of $56,000.00 to $88,000.00 per year, as well as a comprehensive benefits package, including 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.
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.
