What are the responsibilities and job description for the Raman/PAT Implementation Engineer position at Meet Life Sciences?
Position Summary
We are seeking a hands-on Raman/PAT Implementation Engineer to support the deployment and integration of Raman spectroscopy within a GMP manufacturing environment. This role is highly technical and execution-focused, requiring someone who can build methods, write procedures, support validation, and embed the system into operations—not just provide oversight.
The ideal candidate will bring a strong blend of analytical science, PAT expertise, and GMP systems/automation experience, with the ability to operate both in the lab and across manufacturing systems.
Key Responsibilities
Raman / PAT Implementation
- Lead hands-on implementation of Raman spectroscopy-based PAT solutions
- Develop, optimize, and execute analytical methods using Raman technology
- Support integration of Raman tools into manufacturing workflows and control strategies
- Collaborate with MSAT, Analytical Development, and Manufacturing teams to ensure successful deployment
Method Development & Validation
- Develop and document analytical methods, SOPs, and work instructions
- Execute and support method qualification and validation activities
- Ensure alignment with GMP, FDA, and ICH guidelines
GMP Systems & Automation Support
- Implement and configure network and automation systems supporting GMP manufacturing (e.g., MES, SCADA, PLC-integrated environments)
- Support installation and integration of manufacturing equipment and IT/OT infrastructure
- Utilize ROMMON (ROM Monitor) for device initialization, firmware recovery, and system restoration
Validation & Compliance
- Execute IQ/OQ/PQ protocols for analytical systems and supporting infrastructure
- Ensure systems meet data integrity, security, and audit readiness requirements
- Maintain inspection-ready documentation across all activities
Troubleshooting & Technical Support
- Troubleshoot analytical, system, network, and firmware-level issues to minimize downtime
- Provide hands-on technical support during implementation and operational phases
Documentation & Cross-Functional Collaboration
- Develop and maintain technical documentation, SOPs, and configuration records
- Partner cross-functionally with MSAT, QA, IT/OT, Validation, and Manufacturing
- Support tech transfer and production readiness activities