Senior Quality Assurance Validation Specialist
Regeneron
August 18, 2026
On-site
East Greenbush, NY
Operations
Responsibilities:
- Generate, execute, and/or review master and completed qualification/validation protocols, summary reports, and associated data to meet regulatory requirements, SOPs, specifications, and acceptance criteria.
- Analyze test results and determine acceptability vs. pre-determined criteria.
- Investigate/troubleshoot problems and recommend solutions or improvements.
- Review/edit/approve deviation notifications, deviation investigations, and corrective actions.
- Review/edit/approve change controls, SOPs, reports, and other documentation.
- Coordinate with departments and outside contractors/vendors to complete validation tasks.
- Execute real-world and simulated transport studies (e.g., gross-damage inspections, pallet configuration assessments, packaging material qualification).
- Conduct temperature mapping for controlled environments and distribution lanes.
- Program/deploy instrumentation to capture vibration and shock profiles; analyze data to inform packaging design/handling recommendations.
- Program humidity and pressure sensors; interpret datasets for test plans and root-cause analysis.
- Apply ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification.
- Perform small-parcel and palletized-load qualifications (planning, execution, reporting).
- Follow cleanroom/gowning requirements, including removal of jewelry/makeup/nail adornments.
Qualifications/Requirements:
- B.S. in life sciences or related field; proven experience may substitute.
- QA Validation Specialist: 4+ years of experience.
- Sr. QA Validation Specialist: 6+ years of experience.
Benefits (if part of job description):
- Student loan paydown program & tuition reimbursement; family care benefits; relocation assistance; inclusion/culture and well-being programs.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.
- Generate, execute, and/or review master and completed qualification/validation protocols, summary reports, and associated data to meet regulatory requirements, SOPs, specifications, and acceptance criteria.
- Analyze test results and determine acceptability vs. pre-determined criteria.
- Investigate/troubleshoot problems and recommend solutions or improvements.
- Review/edit/approve deviation notifications, deviation investigations, and corrective actions.
- Review/edit/approve change controls, SOPs, reports, and other documentation.
- Coordinate with departments and outside contractors/vendors to complete validation tasks.
- Execute real-world and simulated transport studies (e.g., gross-damage inspections, pallet configuration assessments, packaging material qualification).
- Conduct temperature mapping for controlled environments and distribution lanes.
- Program/deploy instrumentation to capture vibration and shock profiles; analyze data to inform packaging design/handling recommendations.
- Program humidity and pressure sensors; interpret datasets for test plans and root-cause analysis.
- Apply ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification.
- Perform small-parcel and palletized-load qualifications (planning, execution, reporting).
- Follow cleanroom/gowning requirements, including removal of jewelry/makeup/nail adornments.
Qualifications/Requirements:
- B.S. in life sciences or related field; proven experience may substitute.
- QA Validation Specialist: 4+ years of experience.
- Sr. QA Validation Specialist: 6+ years of experience.
Benefits (if part of job description):
- Student loan paydown program & tuition reimbursement; family care benefits; relocation assistance; inclusion/culture and well-being programs.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.