MES Project Manager - Singapore
Advanced Manufacturing Tech Solutions (AMTSOL) · Singapore ·
- Category
- Project management
- Experience
- 10+ years
The MES Project Manager leads the end-to-end implementation and validation of Manufacturing Execution Systems within pharmaceutical environments. The role focuses on ensuring cGMP and CSV compliance while managing cross-functional teams and integrating MES with automation and ERP systems.
Job Description / Capsule
We are seeking an experienced MES Project Manager to lead the implementation and validation of Manufacturing Execution Systems (MES) in pharmaceutical manufacturing operations. This role will oversee project delivery, ensure compliance with cGMP and CSV standards, and manage cross-functional teams to deliver robust digital manufacturing solutions.
Key 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
Education, Skills & Experience
Essential:
- 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.
Desirable:
- Experience with DeltaV, HBV, SAP integration.
- Familiarity with digital validation platforms (Kneat, Veeva, ValGenesis).
- PMP or equivalent project management certification.
- Exposure to multi-site pharma MES rollouts.
- Additional language proficiency.