Pharma MES Delivery Lead (cGMP/CSV)

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Advanced Manufacturing Tech Solutions seeks an experienced MES Project Manager to lead the implementation and validation of Manufacturing Execution Systems in pharmaceutical manufacturing. You will oversee project delivery, ensure compliance with cGMP and CSV standards, and manage cross-functional teams to deliver robust digital manufacturing solutions.

The role requires 10+ years in pharma MES projects, strong leadership, and hands-on experience with MES platforms like Werum PAS-X, Siemens

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related discipline.
• 10+ years' experience in pharma/life sciences MES projects.
• Proven track record in MES project management and delivery.
• Strong knowledge of MES platforms (Werum PAS-X, Siemens Opcenter, GE Proficy, etc.).
• Hands-on experience with CSV, cGMP compliance, and validation frameworks.
• Excellent leadership, communication, and stakeholder management skills.

Responsibilities

• Lead end-to-end MES project execution (planning, design, implementation, validation, and go-live).
• Define MES strategies, scope, and integration with automation systems.
• Ensure compliance with CSV, cGMP, GAMP 5, and regulatory requirements.
• Manage project schedules, budgets, and deliverables.
• Collaborate with QA, CQV, Engineering, IT/OT, and Operations teams.
• Oversee preparation and approval of MES documentation (URS, FS, DS, IQ/OQ/PQ).
• Drive digital initiatives including Electronic Batch Records (EBR) and data integrity compliance.
• Provide leadership, mentoring, and guidance to MES engineers and project teams.
• Support audits, inspections, and regulatory readiness

Skills

Project management

Leadership

Stakeholder management

Communication

Regulatory awareness

Education

Bachelor's degree in Engineering/Computer Science or related

Tools

WERUM PAS-X

Siemens Opcenter

GE Proficy

DeltaV integration

HBV integration

SAP integration

Job description

Advanced Manufacturing Tech Solutions seeks an experienced MES Project Manager to lead the implementation and validation of Manufacturing Execution Systems in pharmaceutical manufacturing. You will oversee project delivery, ensure compliance with cGMP and CSV standards, and manage cross-functional teams to deliver robust digital manufacturing solutions.

The role requires 10+ years in pharma MES projects, strong leadership, and hands-on experience with MES platforms like Werum PAS-X, Siemens