PAT Specialist (Principal/SME) — Process Analytical Technology

Pyramid Consulting, Inc; Canada; Teletrabalho; CAD 96 000 - 103 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) plan

Paid sick leave

Resumo da oferta

Pyramid Consulting, Inc. is seeking a PAT Specialist (Principal/SME) for a 06-12+ month contract in Canada with remote work options. The role focuses on Process Analytical Technology, GMP compliance, and validation across manufacturing operations.

Strong facilitation and stakeholder management skills are required. Responsibilities include leading discovery workshops, translating needs into actionable documentation, evaluating PAT options, ROI modeling, and coordinating cross-functionally to

Qualificações

• Must have GMP, MES, and stakeholder management experience.
• Proven track record implementing PAT including validation strategy and regulatory/GMP requirements.
• Strong knowledge of manufacturing operations and interfaces across Manufacturing, Quality, Engineering, and Digital/IT.
• Experience with electronic records/data integrity and computerized system implementation/validation practices.

Responsabilidades

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

Conhecimentos

GMP knowledge

MES (Manufacturing Execution System)

Stakeholder management

PAT implementation

Validation strategy

Regulatory compliance

Workshop facilitation

Data integrity

Descrição da oferta de emprego

Immediate need for a talented PAT Specialist (Principal/SME) — Process Analytical Technology. This is a 06-12+ Months Contract opportunity with long-term potential and is located in Canada (Remote).

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.

Key Requirements and Technology Experience

• 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.

Our client is a leading IT Industry and we are currently interviewing to fill this and other similar contract positions.

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.