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Regeneron

Associate Automation Systems Administrator

Regeneron

. Administer automated/computerized system software and firmware to meet cGMP and procedural requirements .

Posted 10/12/2026full-timeMenands • New York • United StatesMid-LevelSenior💰 $62,355 - $92,400 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in administering automated systems and ensuring compliance with cGMP standards, including configuration management and software validation. Proficient in conducting risk assessments and supporting biopharmaceutical processes through effective documentation and communication.

Highest-signal resume keywords
CGMP ComplianceSoftware ValidationConfiguration ManagementRisk AssessmentBiotech/Pharma Manufacturing Knowledge

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Automated System AdministrationTest Plan ExecutionData RecoveryProcess Control SystemsConfiguration Specification AuthoringChange Control ManagementRoot Cause AnalysisUser Access AdministrationSoftware Configuration DocumentationBiopharmaceutical Process Knowledge
Soft Skills
Excellent Communication SkillsInterpersonal SkillsAbility to Work IndependentlyTeam Collaboration
Tools & Technologies
Word Processing SoftwareSpreadsheet SoftwarePowerPointDatabase Management Software
Industry Keywords
CGMPBiotechPharmaceuticalRegulatory ComplianceQuality PoliciesLaboratory TestingManufacturing Processes

About the role

Key responsibilities & impact
  • Administer automated/computerized system software and firmware to meet cGMP and procedural requirements
  • Document COTS software configurations for biopharmaceutical process, monitoring and testing systems
  • Execute test plans to demonstrate software suitability
  • Support authoring and maintenance of configuration specifications for cGMP automated and computerized systems
  • Back up and archive system data to meet defined RTO and RPO; perform data recovery as needed
  • Manage configurations, recipes and methods according to procedure
  • Support system SAT/FAT, validation and qualification efforts
  • Support review of system lifecycle design documentation
  • Process change control requests, including requirements/design specifications, test plans, technical evaluations and quality risk assessments
  • Follow relevant system software SOPs and policies
  • Provide end-user application support and basic hardware troubleshooting, including vendor coordination
  • Support change controls, NOEs, risk assessments, impact statements and corrective/preventive action plans
  • Assist with investigations and root cause analysis for departmental non-compliance issues
  • Administer user access, including adding, modifying and removing users and defining user types, groups and security settings

Requirements

What you’ll need
  • BS/BA in Science/Engineering or related field preferred
  • 1–2 years of relevant experience in a manufacturing, laboratory, or IT setting
  • Minimum 3 years of relevant experience in a manufacturing, laboratory, or IT setting may be considered in lieu of the educational requirement
  • Working knowledge of process control systems and product release testing systems preferred
  • Current knowledge of cGMP biotech/pharma operations, regulatory and quality policies, procedures and documentation methods
  • Knowledge of risk assessments
  • Ability to work independently and as a project team member
  • Knowledge of biotech/pharma manufacturing processes, supporting laboratory testing, regulatory requirements, and related terminology
  • Excellent writing, communication and interpersonal skills
  • Working knowledge of word processing, spreadsheet, PowerPoint and database management software

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