Senior MES Project Lead — Digital Pharma Manufacturing

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

Job summary

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

The role requires a Bachelor's degree in engineering or computer science, 10+ years in pharma MES projects, and hands-on knowledge of MES platforms such as Werum

Qualifications

• Bachelor's degree in engineering, computer science, or related discipline required.
• 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).
• 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 (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

Communication

Education

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

Tools

DeltaV

HBV

SAP integration

Kneat

Veeva

ValGenesis

Job description

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

The role requires a Bachelor's degree in engineering or computer science, 10+ years in pharma MES projects, and hands-on knowledge of MES platforms such as Werum