Job Description
Job Description
Role & Responsibilities
Looking for a person who knows Lab X to handle rollout and ensure instruments are fully operational.
- Key Responsibilities:
- Instrument Rollout & Compliance
- For Lab X - Deploy instruments, ensure functionality, and validate connections.
- Work in gowning & process areas.
- Follow GxP, pharma/biotech regulations, and ALCOA principles.
- Software & IT Aspects
- System administration, and user access controls.
- Software rollout and data integrity considerations (data types, file types, software-database connections).
- Network & domain configurations.
- Validation & Documentation
- Equipment validation & troubleshooting.
- Work with ValGenesis.
- Heavy documentation responsibility, working alongside Software SMEs.
- IOQ, vendor coordination, preliminary and full PQ with Manufacturing & QC before release to production.
- Training & Support
- Train Manufacturing & QC teams on device usage.
- Conduct working sessions.
Job Requirements
- Experience in:
- GxP compliance, pharma/biotech.
- IT knowledge—networking, system configurations, troubleshooting.
- Software administration and validation.
- Equipment validation processes (IOQ, PQ, vendor coordination).
- Strong documentation skills.
- Knowledge of Lab X software.
Requirements
- Experience in:
- GxP compliance, pharma/biotech.
- IT knowledge—networking, system configurations, troubleshooting.
- Software administration and validation.
- Equipment validation processes (IOQ, PQ, vendor coordination).
- Strong documentation skills.
- Knowledge of Lab X software.