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Senior Validation Engineer

Indianapolis 110K - 145K Permanent

Job Responsibilities:

  • Execute qualification protocols on clean utilities, autoclaves, fillers, laboratory instruments, controlled temperature units, and other critical systems.
  • Provide validation support to clients for product launches and new equipment qualifications, ensuring customer satisfaction.
  • Oversee validation aspects of capital expansion projects and facility build-outs, ensuring that new installations meet regulatory requirements.
  • Take ownership of creating and updating Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines related to equipment validation.
  • Review facility changes and provide recommendations for re-validation and re-qualification of existing equipment based on risk assessments.
  • Evaluate risks in equipment processes and review validation requirements and design deliverables to ensure compliance.
  • Work closely with Engineering, Operations, and other departments to support process improvements and ongoing validation efforts.
  • Conduct validation activities in accordance with approved protocols, identifying any deviations or protocol excursions and proposing corrective actions.
  • Stay updated on industry trends and regulatory expectations, proposing modifications to validation programs to ensure ongoing compliance.

Qualifications:

  • Bachelor’s degree or higher in a STEM discipline.
  • 5-8 years of experience in validation or a related field.
  • 4+ years of experience in a GMP-regulated industry.
  • Strong understanding of qualification activities for equipment, utilities, and laboratory systems.
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