Executive Director, Automation, Robotics, and Technical Writing – Cell Therapy, Process Sciences, Analytics and Technology
US – Santa Monica Colorado Avenue – CA, United States
USD 255K-380K Executive-level Full Time
Tasks
- Architect validated instrument connectivity
- Coordinate cross functional regulatory interactions
- Define SLAs for data latency and uptime
- Define SOPs and training for compliance
- Define automation and robotics strategy
- Define standard data models and metadata schemas
- Deliver technical writing COE
- Develop CSV for automated systems
- Drive change management and user adoption
- Enforce FAIR principles
- Ensure ALCOA plus data integrity
- Ensure GxP alignment
- Establish target operating model
- Implement audit trails and electronic signatures
- Implement event driven API data flows
- Implement role based access control for OT
- Integrate instruments with ELN and LIMS
- Integrate with MES and electronic batch records
- Integrate with SCADA and DCS
- Lead automation controls engineering team
- Lead talent recruitment and development
- Maintain change control for integrations
- Manage certificates and secure patching
- Oversee closed system unit operations deployment
- Partner with IT and cybersecurity
- Perform CSV for digital interfaces
- Perform vulnerability management
- Review workflows to improve traceability
- Stand up observability and monitoring
- Standardize protocol templates
Perks/Benefits
Skills/Tech-stack
AI/ML | ALCOA plus | API | Access Control | Alerting | Aseptic Processing | Audit Trail | Automation | BSL-2 | CMC | CSV | Certificate management | Change Control | Change Management | Closed Loop | Closed-loop systems | Comparability | Cybersecurity | DCS | Data Historian | Data Integrity | Data Lake | Data Modeling | Data Warehouse | Digital integration | ELN | Electronic Signatures | Event Driven | Event-driven architecture | FAIR | GxP | Incident Response | LIMS | Logging | MES | Metadata Schema | Metrics | Observability | Ontology | Process control | Protocol Authoring | Public Key Infrastructure | Public key | Robotics | Role-Based Access | Role-Based Access Control | S&OP | SCADA | SLAs | Secure patching | Single-use systems | Technical writing | Technology Transfer | Training | Vulnerability Management
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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