Associate QA Validation Specialist

Regeneron

. Validate and qualify equipment, systems, and processes in accordance with regulatory requirements .

Posted 10/13/2026full-timeRensselaer • New York • United StatesSeniorLead💰 $62,355 - $92,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in validating and qualifying equipment, systems, and processes in compliance with regulatory requirements, while effectively managing projects and collaborating with cross-functional teams. Proficient in generating and reviewing validation protocols and documentation, with a strong focus on continuous improvement and problem-solving.

Highest-signal resume keywords

Validation Protocol DevelopmentRegulatory ComplianceProject ManagementData AnalysisTeam Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ValidationQualificationData AnalysisProblem SolvingDocumentation ReviewSOP DevelopmentChange ControlDeviation InvestigationMicrosoft SuiteEngineering

Soft Skills

Effective CommunicationTime ManagementIntegrityTeamworkTransparency

Industry Keywords

Manufacturing StandardsRegulatory AuditsContinuous ImprovementDeviation NotificationsCorrective Actions

About the role

Key responsibilities & impact

Validate and qualify equipment, systems, and processes in accordance with regulatory requirements
Support, follow, and implement company manufacturing standards, policies, and procedures
Generate, implement, and/or review master and completed qualification and validation protocols, summary reports, and associated data
Analyze testing results and determine acceptability against predetermined criteria
Investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements
Review, edit, and approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation
Coordinate with departments and outside contractors/vendors to complete validation tasks
May supervise, provide direction, and assign work to Validation Specialists and/or contingent workers
Manage projects and prepare status reports
May present at internal and external regulatory audits
Perform other duties assigned by management

Requirements

What you’ll need

BS/BA in Engineering, Chemistry, or Life Sciences
0–2 years of relevant experience for an Associate
2+ years of relevant experience for a Specialist
5+ years of relevant experience for a Senior Specialist
8+ years of relevant experience for a Principal Specialist
Proven experience may substitute for the education requirement
Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)
Ability to maintain integrity and honesty at all times
Ability to work independently or as part of a team
Ability to communicate with transparency
Effective time management skills
Ability to gather and organize information
Ability to meet commitments on time
Ability to perform well-defined tasks
Ability to identify continuous improvement needs
Some travel may be required
Background checks may be conducted, including verification of identity, right to work, and educational qualifications

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required