Senior Validation Engineer

2 weeks ago


Social Circle, Georgia, United States BioSpace, Inc. Full time
About the Role

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
Requirements
  • 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
What We Offer

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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