MES Project Lead for GMP-Driven Digital Manufacturing

Amaris Consulting | Part of Mantu; Toronto; On-site; CAD 90,000 - 130,000; Full time

Job summary

Amaris Consulting is seeking an MES Project Manager to drive a major pharmaceutical MES program in Canada, coordinating Quality, Manufacturing, IT, and external partners to move from initiation to go-live and post-implementation monitoring.

You’ll oversee budgets, planning, risks, and stakeholder communication, with experience in PAS-X or similar MES platforms being a strong advantage.

Qualifications

• 5+ years of experience in life sciences or a regulated manufacturing environment.
• Delivery experience with MES projects or digital/software projects in pharmaceutical manufacturing.
• Project management covering budgets, resources, timelines, risks, and cross-functional teams.
• Familiarity with GMP and computerised system validation.

Responsibilities

• Lead MES implementation, rollout, upgrade, and enhancement projects from initiation through go-live and post-implementation monitoring.
• Own the project plan, budget, risks, dependencies, governance, and status reporting for site leadership.
• Translate operational needs into clear user requirements with Quality, Manufacturing, and technical teams.
• Coordinate digitisation of paper batch records and master data/recipes management.
• Oversee system testing for new use cases and follow up on deviations after go-live.
• Ensure project deliverables meet GMP and computerised system validation requirements in collaboration with Validation and Quality teams.
• Coordinate risk assessments, test strategies, requirements traceability, and validation documentation.
• Manage change controls and impact assessments for MES changes with stakeholders.
• Coordinate activities with software vendors and integration partners and review deliverables for acceptance against requirements.
• Identify process and system improvements after go-live.

Skills

MES projects

Life sciences

Regulated manufacturing

Project management

GMP knowledge

Education

Bachelor's degree in engineering or life sciences

Tools

PAS-X by Körber

Job description

Amaris Consulting is seeking an MES Project Manager to drive a major pharmaceutical MES program in Canada, coordinating Quality, Manufacturing, IT, and external partners to move from initiation to go-live and post-implementation monitoring.

You’ll oversee budgets, planning, risks, and stakeholder communication, with experience in PAS-X or similar MES platforms being a strong advantage.