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About the Role
Regeneron is seeking a Sr. QA Validation Specialist to join the Quality Assurance team. This role involves validating equipment, systems, and processes in accordance with regulatory requirements and supporting company manufacturing standards. The position offers an opportunity to contribute to a science-driven organization making a difference to patients worldwide.
Responsibilities
- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks
- Executed real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
- Conducts temperature mapping for controlled environments and distribution lanes
- Programs and deploys instrumentation to capture vibration and shock profiles; analyzed data to inform packaging design and handling recommendations
- Programs humidity and pressure sensors and interpreted datasets to support test plans and root-cause analysis
- Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
- Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting
Requirements
- Full cleanroom attire required (including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
- Background checks may be conducted in accordance with laws to verify identity, right to work, and educational qualifications.
Skills
- QA Validation
- Equipment validation
- System validation
- Process validation
- Regulatory requirements
- Manufacturing standards
- Protocol generation
- Protocol execution
- Protocol review
- Summary report generation
- Data analysis
- Problem-solving
- Deviation investigation
- Corrective actions
- Change control review
- SOP review
- Transport studies
- Packaging qualification
- Temperature mapping
- Vibration and shock analysis
- Humidity and pressure sensor programming
- ASTM standards
- ISTA standards
- Cold-chain shipping design
- Small-parcel qualification
- Palletized-load qualification
Location
- Rensselaer, New York, United States
Work Type
- On-site
- Full-time
Experience Level
- Sr. QA Validation Specialist: 6+ years of experience
- Level will be determined based on experience
Education Level
- B.S. in life sciences or related field; may substitute proven experience for education requirement
Salary/Compensations
- $67,400.00 - $128,700.00
Benefits
- Student loan paydown program
- Tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.