Validation Engineer
2 weeks ago
As a Validation Engineer, you will play a critical role in supporting site projects, technical transfers, and ongoing validation maintenance. You will oversee the design, authorship, and execution of commissioning, qualification, and validation studies for various disciplines, including facilities, utilities, and equipment qualification, units operations automation, and computerized systems validation.
Key Responsibilities- Design, author, and execute commissioning, qualification, and validation studies
- Partner with subject matter experts to ensure efficient execution of testing strategies
- Conduct risk and impact assessments collaboratively
- Support the development of standard operating procedures and validation assessments
- Work with customers on technical issues, project timelines, and validation support
- Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team
- Support the development of best demonstrated validation practices within the validation department
- Bachelor's degree in an Engineering discipline (preferred)
- Minimum 5 years of 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)
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint
- Knowledge of industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are committed 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 protected by law.
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Senior Validation Engineer
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Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is seeking a highly skilled Senior Validation Engineer to support site projects, technical transfers, and ongoing validation maintenance. As a key member of our Engineering Validation team, you will be responsible for designing, authoring, and executing commissioning, qualification, and validation studies for various disciplines.Key...
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Senior Validation Engineer
2 weeks ago
Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the RoleWe are seeking a highly skilled Senior Validation Engineer 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 ResponsibilitiesDesign, author, and execute commissioning, qualification, and validation studies for...
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Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is seeking a highly skilled Senior Validation Engineer to join our team in Social Circle, GA. 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 ResponsibilitiesDesign, author, and execute commissioning, qualification, and validation studies for...
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