PAT Specialist @ 100% Remote (EST Hours Support)

JD

The PAT Specialist will partner with manufacturing SMEs, GMT, VMRD, Product Owners, Quality, Regulatory, Engineering and ZTD to drive discovery, define requirements, and ensure implementation readiness for PAT use cases across the manufacturing network. This is a hands-on, facilitative role that blends deep PAT subject-matter expertise with strong business analysis and delivery leadership, ensuring solutions are fit-for-purpose, GMP-ready, and scalable.

Key Responsibilities:

• Lead structured discovery workshops with SMEs to define scope, business value, and success measures for PAT use cases.
• Translate manufacturing needs into clear requirements and delivery-ready documentation (process, data, system, validation, and operating model needs).
• Evaluate PAT technology options (fit, feasibility, integration, and compliance), supporting vendor engagement and selection.
• Obtain vendor quotes and build cost models; develop ROI/financial return cases for prioritized PAT use cases.
• Build and maintain integrated PAT project timelines, explicitly incorporating GMP, validation, data integrity, and regulatory deliverables.
• Coordinate cross-functionally with Manufacturing, Quality, Engineering, VMRD, Regulatory and ZTD to align on responsibilities, controls, and readiness.
• Support implementation partners through requirements clarification, risk/issue management, and milestone execution toward pilot and scale-up.

Required Experience and Capabilities:

• Demonstrated experience implementing PAT, including technology selection, validation strategy and regulatory/GMP requirements.
• Strong knowledge of manufacturing operations and the interfaces across Manufacturing, Quality Engineering, and Digital/IT.
• Working expertise in GMP expectations, electronic records/data integrity, and computerize system implementation/validation practices.
• Excellent workshop facilitation, stakeholder management, documentation, and executive-ready communication skills.