Orise
Linkedin · Posted 5d ago
AI Driven Automation Solutions Architect (Pharma)
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Indexed description
Your ResponsibilitiesWe are seeking an Engineer to provide on-site engineering and application support for pharmaceutical manufacturing operations in New Albany, Ohio. This role supports Line Clearance and other DISO applications, while also contributing to the operation and support of production-grade AWS-based machine learning platforms used in regulated manufacturing environments. This is a newly created role intended to strengthen on-site support, improve response times, and ensure reliable, compliant operation of critical manufacturing and digital systems.
Your responsibilities
- Provide on-site engineering and application support for Line Clearance systems and other DISO applications
- Support day-to-day operations, troubleshooting, and incident resolution for production and quality-critical systems
- Collaborate with manufacturing, quality, IT, and digital teams to ensure system availability, performance, and compliance with GMP requirements
- Support AWS-based ML platforms used in manufacturing and quality use cases, including monitoring, operational support, and controlled deployments
- Assist with system configuration, testing, validation, and documentation activities in accordance with site and regulatory standards
- Participate in change management activities, including impact assessments, implementation support, and post-change verification
- Support investigations and root cause analysis related to application or data issues
- Coordinate with global engineering, IT, and data platform teams as needed
- Maintain clear documentation and communication aligned with site procedures and operational best practices
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or a related technical discipline
- Experience supporting manufacturing or quality systems in regulated environments (pharmaceutical, biotech, or life sciences)
- Experience with Line Clearance processes and Machine Learning applications
- Strong troubleshooting, analytical, and problem-solving skills
- Ability to work effectively in an on-site, cross-functional environment
- Strong written and verbal communication skills
- Experience supporting production-grade AWS-based machine learning platforms, including:
- AWS SageMaker Pipelines for ML workflow orchestration
- Model versioning and governance using Amazon SageMaker Model Registry or equivalent tools
- Deployment and operation of ML solutions across multi-account AWS environments (development, validation, and production)
- Understanding of MLOps best practices, including model lifecycle management, CI/CD for ML, monitoring, and controlled promotion across environments
- Familiarity with AWS Well-Architected Framework principles, particularly security, reliability, and operational excellence, as applied to ML platforms
- Experience working in GMP-regulated manufacturing environments
- Exposure to system validation, change control, and regulated documentation practices
- Experience supporting cloud-based data or analytics platforms in life sciences
- Knowledge of pharmaceutical manufacturing workflows and quality systems
- Prior experience supporting Amgen systems or similar enterprise manufacturing environments
- Human Oversight and Accountability – AI is used solely to augment, not replace human judgment. All decisions regarding CV/resume screening, who to interview, and who to hire are made by ATS hiring managers and recruitment teams.
- Transparency and Data Protection – ATS will inform candidates when AI is being used to transcribe an interview to ensure our notes are complete and accurate. Candidates may choose whether or not to allow the use of transcript. All applicant data, including AI-generated interview notes, is treated as a confidential recruitment record and managed in accordance with applicable data protection laws.
- Fairness and Equality – ATS is committed to ensuring the use of AI is vetted and assessed to ensure it is not creating or perpetuating bias or discrimination.
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