Senior Automation Systems Administrator, Manufacturing & Lab Support
Regeneron
August 06, 2026
On-site
Menands, NY
IT
Discover Your Role
- Configure and maintain cGMP software for process control, monitoring, and testing; manage user access, system security, configuration management, and recipe/method management to meet regulatory requirements
- Determine data backup and archive configurations to meet defined RTO/RPO targets; design and maintain recovery processes
- Process change control requests (requirements/design, test plans, technical evaluations, quality risk assessments) to keep systems compliant
- Support and lead SAT/FAT, validation, and qualification; create and execute testing/qualification protocols for automated equipment
- Author/review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and CAPAs; lead investigations and root cause analyses for non-compliance
- Lead small-to-medium projects for corrective action, software performance improvement, and new equipment/software implementations
- Provide advanced technical automation support/troubleshooting to Manufacturing, Quality Control, and Facilities per SOPs
- Support integration with LIMS/Historian; draft/approve/follow relevant SOPs/policies; identify continuous improvement opportunities
This Role Requires
- BS/BA in Science, Engineering, or related field + 5+ years relevant experience (or equivalent)
Preferred Skills/Experience
- Direct experience in pharmaceutical/biopharmaceutical manufacturing facility
- Advanced experience configuring/troubleshooting process control, monitoring, and product release testing systems (design/installation)
- Expertise in Software Lifecycle Documentation and test plans for cGMP equipment using GAMP 5
- Current knowledge of cGMP biotech/pharma operations, regulatory/quality policies, procedures, and documentation methods
Physical/Cleanroom Requirements
- Full cleanroom attire; ability to remove jewelry/makeup/nail adornments
- Ability to perform physical requirements up to 10 hours in cleanroom environment (including lifting up to 50 lbs)
Application Instructions
- Apply now.
- Configure and maintain cGMP software for process control, monitoring, and testing; manage user access, system security, configuration management, and recipe/method management to meet regulatory requirements
- Determine data backup and archive configurations to meet defined RTO/RPO targets; design and maintain recovery processes
- Process change control requests (requirements/design, test plans, technical evaluations, quality risk assessments) to keep systems compliant
- Support and lead SAT/FAT, validation, and qualification; create and execute testing/qualification protocols for automated equipment
- Author/review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and CAPAs; lead investigations and root cause analyses for non-compliance
- Lead small-to-medium projects for corrective action, software performance improvement, and new equipment/software implementations
- Provide advanced technical automation support/troubleshooting to Manufacturing, Quality Control, and Facilities per SOPs
- Support integration with LIMS/Historian; draft/approve/follow relevant SOPs/policies; identify continuous improvement opportunities
This Role Requires
- BS/BA in Science, Engineering, or related field + 5+ years relevant experience (or equivalent)
Preferred Skills/Experience
- Direct experience in pharmaceutical/biopharmaceutical manufacturing facility
- Advanced experience configuring/troubleshooting process control, monitoring, and product release testing systems (design/installation)
- Expertise in Software Lifecycle Documentation and test plans for cGMP equipment using GAMP 5
- Current knowledge of cGMP biotech/pharma operations, regulatory/quality policies, procedures, and documentation methods
Physical/Cleanroom Requirements
- Full cleanroom attire; ability to remove jewelry/makeup/nail adornments
- Ability to perform physical requirements up to 10 hours in cleanroom environment (including lifting up to 50 lbs)
Application Instructions
- Apply now.