About the role
About the Role:
Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
Ensure systems remain in a qualified state. Act as technical owner for system lifecycle including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning
Monitor system reliability and performance. Develop and implement engineering solutions to complex problems. Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices. Support development of site staff on technical and procedural topics
How you will contribute:
- Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
- Implement system modifications under cGMP change control
- Develop and execute FAT, commissioning protocols, and qualification protocols
- Develop calibration and preventative maintenance plans
- Lead deviation investigations and implement corrective and preventative actions
- Participate in capital planning, spending, and tracking
- Serve as project manager on small to medium projects under $5M
- Interface with cross-functional teams to meet project goals
- Stay current with industry best practices and technologies
- Complete required training within timeframe
- Selecting technologies, designing equipment, and diagnosing process issues
- Making data-driven decisions using engineering principles
- Ensuring impact to product quality, safety, reliability, and throughput
- Maintaining regulatory compliance and validation requirements
- Troubleshooting factory floor issues and supporting capacity planning
- Managing impact to uptime, batch continuity, and manufacturing schedule
- Responding to urgency and severity of equipment failures
- Determining escalation thresholds
- Balancing short-term mitigation versus long-term solutions
- Perform other duties as assigned