Regeneron · 2 days ago
Investigation Specialist (Technical Operations)
Rensselaer, NY
Full-time
Onsite
New Grad, Entry, Mid, Senior Level
$62K/yr - $129K/yr
0+ years expRegeneron is currently looking to fill an Investigation Specialist position supporting their Technical Operations team. This role involves performing compliance-related tasks vital for completing investigations and implementing corrective actions to support manufacturing operations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
Communicating findings and recommendations at group meetings
Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
Participating in and/or leading cross-functional study teams to get results, support and or author investigations
Gathering, trending, and analyzing process related data to drive consistency and timeliness
Documenting all training
Training new employees on investigative processes and techniques
Coordinating and/or leading cross-functional meetings with multiple departments
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or related field
0-2+ years of relevant experience for Associate Specialist
2+ years of relevant experience for Specialist
5+ years of relevant experience for Senior Specialist
Proven experience may substitute for education requirement
Ability to independently investigate non conformances and prevent reoccurrences
Ability to prepare investigation reports with recommendations
Ability to analyze and evaluate information captured through investigations
Ability to communicate findings and recommendations at group meetings
Ability to review completed batch records and logbooks in accordance with cGMP standards
Ability to review, edit, and revise controlled documents in accordance with cGMP standards
Ability to monitor production processes to acquire vital data
Ability to participate in and/or lead cross-functional study teams
Ability to gather, trend, and analyze process related data
Ability to document all training
Ability to train new employees on investigative processes and techniques
Ability to coordinate and/or lead cross-functional meetings
Preferred
Understanding of biologics manufacturing operations
Excel in a quality driven organization
Organized with attention to detail
Ability to prioritize multiple assignments and changing priorities
Ability to learn and utilize computerized systems for daily performance of tasks
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2025-12-29
Company data provided by crunchbase