Senior Automation Systems Administrator - Validation

About the role

The Senior Automation Systems Administrator will configure and maintain cGMP software for process control, monitoring, and testing; manage user access, system security, configuration management, and recipe and method management to meet regulatory requirements.

Responsibilities

• Determine data backup and archive requirements and configurations to meet defined RTO and RPO targets; design and maintain recovery processes
• Ensure systems remain in a compliant state by processing change control requests including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Support and lead system SAT/FAT, validation, and qualification efforts; generate and execute testing and qualification protocols for automated process, monitoring, and testing equipment
• Initiate, author, and review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and corrective and preventive action plans; lead investigations and root cause analyses for non-compliance issues
• Lead multiple small to medium-sized projects related to corrective action, software performance improvement, and new equipment and software implementation
• Provide advanced technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities in accordance with established SOPs and departmental practices
• Support system integration with existing platforms such as LIMS and Historian; draft, approve, and follow relevant system software SOPs and policies; identify opportunities for continuous improvement in processes, procedures, and architecture standards

Requirements

Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred

Advanced experience configuring and troubleshooting process control, monitoring, and product release testing systems including design and installation

Expertise in developing Software Lifecycle Documentation, software design documents, technical evaluations, and test plans for cGMP process equipment following GAMP 5 guidelines

Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods

Qualifications

BS/BA in Science, Engineering, or a related field with 5+ years of relevant experience

May consider equivalent combination of education and experience

Skills

Strong understanding of cGMP regulations and compliance

Experience with process control systems and software

Knowledge of GAMP 5 guidelines

Excellent problem-solving and project management skills

Benefits

Competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits

For additional information about Regeneron benefits in the U.S., please visit here.