Assoc Automation Systems Administrator

Regeneron Pharmaceuticals•Town of Colonie, NY

2d•$62,355 - $92,400•Onsite

About The Position

Responsible for administration of automated/computerized system software and firmware to meet cGMP and procedural requirements. Documents COTS software configuration for biopharmaceutical process, monitoring, and testing systems. Executes test plans to demonstrate suitability of software. Supports authoring and maintains configuration specifications for cGMP automated and computerized systems.

Requirements

BS/BA in Science/Engineering or related field preferred along with 1-2 years of relevant experience in manufacturing/lab/IT setting; will consider minimum 3 years of relevant experience in manufacturing/lab/IT setting in lieu of 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
Must work independently and have project team member capabilities.
Knowledge of biotech/pharma manufacturing process/supporting laboratory testing and regulatory requirements, related terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation.
Excellent writing, communication and interpersonal skills.
Working knowledge of word processing, spreadsheet, PowerPoint and database management software.

Responsibilities

Ensure systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO. Perform recovery of data as needed.
Configuration management and recipe/method management per procedure.
Documents system configurations for cGMP software for process control, monitoring and testing.
Support system SAT/FAT, validation and qualification efforts.
Supports review of system lifecycle design documentation
Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments.
Follow relevant system software SOPs and policies.
Provide end-user support including troubleshooting problems at the application level and basic hardware troubleshooting (includes working with vendors to resolve issues).
Support Change Controls, NOE's, risk assessments, impact statements and corrective/prevention action plans. Assist with investigations and root cause analysis for department issues of non-compliance.
Administer user access - Control access to software systems; add, modify and remove users; define user types, user groups and security settings per procedure.