Pharma MES Project Leader - Compliance & Delivery

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) is seeking an experienced MES Project Manager to lead the implementation and validation of Manufacturing Execution Systems (MES) in pharmaceutical operations.

You will oversee cross-functional teams, ensure cGMP and CSV compliance, and deliver robust digital manufacturing solutions. The ideal candidate has 10+ years in pharma MES projects, hands-on experience with PAS-X/Opcenter/Proficy, and a strong track record in MES project management.

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.

Responsibilities

• Lead end-to-end MES project execution (planning, design, implementation, validation, and go-live).
• Define MES strategies, scope, and integration with automation systems (DeltaV, PLC/DCS, SAP, HBV).
• 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

MES project management

Leadership

Stakeholder management

Regulatory compliance

Education

Bachelor’s degree in Engineering, Computer Science, or related discipline

Tools

Werum PAS-X

Siemens Opcenter

GE Proficy

DeltaV

HBV

SAP integration

Job description

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) is seeking an experienced MES Project Manager to lead the implementation and validation of Manufacturing Execution Systems (MES) in pharmaceutical operations.

You will oversee cross-functional teams, ensure cGMP and CSV compliance, and deliver robust digital manufacturing solutions. The ideal candidate has 10+ years in pharma MES projects, hands-on experience with PAS-X/Opcenter/Proficy, and a strong track record in MES project management.