Senior Validation Engineer
2 weeks ago
We are seeking a highly skilled Senior Validation Engineer to join our team at Takeda. As a key member of our Engineering Validation team, you will play a critical role in supporting site projects, technical transfers, and ongoing validation maintenance.
Key Responsibilities- Design, author, and execute commissioning, qualification, and/or validation studies
- Partner with subject matter experts to ensure efficient execution of testing strategies
- Conduct risk and impact assessments
- Support development and review of standard operating procedures (SOP) and validation assessments
- Communicate 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 development of best demonstrated validation practices within the validation department
- Bachelor's degree in Engineering discipline required
- Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor
- 7 years of relevant experience in a GMP regulated environment
- At least 4 years of commissioning, qualification, and validation (CQV)
- Validation and/or system experience in the following applicable areas: sterilization and aseptic processing validation, cleaning validation of manufacturing equipment, process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification, protein purification from mammalian plasma and/or blood, technical experience with automation platforms
As a Senior Validation Engineer at Takeda, you will have the opportunity to work on complex projects, collaborate with cross-functional teams, and contribute to the development of best practices in validation. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
At Takeda, we are committed to creating a diverse and inclusive workplace that values and respects the contributions of all employees. We are an equal opportunity employer and welcome applications from qualified candidates from diverse backgrounds.
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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 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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