Raman/PAT Implementation Engineer

Meet Life Sciences; Fishers (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

A life sciences company is seeking a hands-on Raman/PAT Implementation Engineer to support the deployment and integration of Raman spectroscopy within a GMP manufacturing environment. The role focuses on building methods, writing procedures, and embedding systems into operations while collaborating with various teams. Required qualifications include a blend of analytical science, PAT expertise, and GMP systems experience to optimize and validate analytical tools for manufacturing workflows.

Qualifications

• Ability to build methods and write procedures for Raman spectroscopy.
• Experience with method qualification and validation in a GMP context.
• Strong troubleshooting skills for analytical and firmware-level issues.

Responsibilities

• Lead implementation of Raman spectroscopy-based PAT solutions.
• Develop and optimize analytical methods using Raman technology.
• Support integration of Raman tools into manufacturing workflows.

Skills

Analytical science

PAT expertise

GMP systems/automation experience

Troubleshooting skills

Technical documentation skills

Tools

Raman spectroscopy

GMP manufacturing systems

MES

SCADA

PLC-integrated environments

Job description

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