PC
PAT Specialist (Principal/SME) — Process Analytical Technology
Pyramid Consulting, Inc
- 🇨🇦 Canada
- Remote
- Staff / Principal
- 13 hours ago
- GMP
- Health insurance
- Pension
13 hours ago
Not enough detail in this posting to match
Job ID:26-31153
Pay Range: CA$70 - CA$75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
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.
- Must have skills: - GMP, MES(Manufacturing Execution System) and Stakeholder management
- 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 computerized system implementation/validation practices.
- Excellent workshop facilitation, stakeholder management, documentation, and executive-ready communication skills.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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PAT Specialist (Principal/SME) — Process Analytical Technology · Pyramid Consulting, Inc