MES Consultant

MES User Project Leader (Gap Analysis Focus)

 

4-Months Contract

Location: Tuas

Salary up to $9,000 depending on experience

Industry : Pharmaceutical

 

 

Role Overview

We are seeking an experienced MES User Project Leader to lead gap analysis–driven MES initiatives at a GMP manufacturing site. This role focuses on assessing current-state processes and systems, identifying gaps against MES, GMP and data integrity requirements, and driving implementation to close those gaps.

 

Key Responsibilities

• Lead MES gap analysis: current-state vs future-state processes, systems, and compliance expectations
• Conduct as-is / to-be process mapping for shop floor manufacturing operations
• Identify and document process, system, data integrity, and regulatory gaps
• Translate gaps into user requirements and functional specifications
• Drive MES implementation activities aligned to gap closure
• Oversee UAT and validation to ensure identified gaps are fully addressed
• Work closely with Manufacturing, Quality, MSAT, Engineering, and Digital teams
• Support audit readiness and regulatory inspections (21 CFR Part 11, EU Annex 11)

 

Requirements

• Bachelor’s degree in Engineering, IT, or related discipline
• 8+ years in pharmaceutical or GMP-regulated manufacturing
• 5+ years hands-on MES experience (PAS-X, Siemens OpCenter / SIMATIC IT, or similar)
• Proven experience performing MES and process gap analysis
• Great understanding of GMP, ALCOA+, CSV (IQ/OQ/PQ), and ISA-95
• Experience translating business gaps into system requirements
• Excellent stakeholder management and documentation skills

 

 

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423