Senior Validation Engineer
$95,000–$130,000 year
On-siteFishers, Indiana, United States
Job Summary
Perform qualification activities on utilities, equipment, and laboratory systems, including clean utilities, autoclaves, and controlled temperature units. Partner with internal customers to support product launches and new equipment qualifications while providing oversight for capital expansion projects. Take ownership in developing Standard Operating Procedures and work instructions, then review facility changes to determine necessary re-validation. Assess risks in processing steps, develop validation requirements, and conduct qualifications in accordance with applicable protocols. Engage with cross-functional teams to monitor validation efforts and identify industry trends to propose program modifications aligning with regulatory expectations.
Required Qualifications
- Bachelor's degree or higher in STEM discipline
- 5-8 years of experience in Validation or related discipline
- 4+ years GMP experience required or other regulated industry
- Physically capable of working onsite
- Qualified applicants must be authorized to work in the United States on a full-time basis
Desired Qualifications
- Master's degree or higher preferred
- Computer System Validation experience preferred
- Cleaning Validation experience preferred
- VHP & Steam Sterilization experience preferred
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