Job Description
Job Title
Senior / Lead MES Technical Consultant – Aspen / APEM
Experience: 15+ years
Location: Singapore
Senior / Lead MES Technical Consultant – Aspen APEM (Pharmaceutical MES)
Experience: 18+ years (Mandatory)
Industry: Pharmaceutical / Life Sciences ONLY (Mandatory)
Location: Singapore
We are seeking a senior-level MES Aspen APEM Technical Consultant with deep, hands-on experience in pharmaceutical manufacturing environments
This role is strictly open to professionals who have designed, implemented, and validated MES systems within regulated pharmaceutical facilities
Candidates without pharmaceutical / life sciences MES experience will NOT be considered.
Mandatory Industry Requirement (Critical)
- Minimum 18+ years of total experience, with significant and proven experience in the pharmaceutical manufacturing industry
- Must have delivered MES implementations for pharma / biotech / API / drug product manufacturing sites
- Must have worked in GxP-regulated environments and supported regulatory audits and inspections
Key Responsibilities
MES Technical & Solution Leadership (Pharma Focused)
- Lead end‑to‑end Aspen APEM MES implementations for pharmaceutical manufacturing sites
- Act as primary MES SME for batch manufacturing, EBR, genealogy, deviation handling, and controlled execution
- Define MES architecture aligned to pharma processes, ISA‑88 / ISA‑95, and global quality standards
Aspen APEM & Pharma MES Execution
- Hands-on leadership with:
- Aspen Production Execution Manager (APEM)
- Electronic Batch Records (EBR)
- Recipe management, batch execution, and exception management
- Integration with DCS / PLC / SAP ERP / LIMS / QMS in pharma plants
Validation, Compliance & Regulatory Readiness
- Lead and approve CSV lifecycle activities
- URS, FRS, DDS
- Risk assessments
- IQ / OQ / PQ
- Validation Summary Reports
- Ensure compliance with:
- GMP / GxP
- FDA 21 CFR Part 11
- EU Annex 11
- Data Integrity (ALCOA+)
- Actively support regulatory inspections (FDA, EMA, MHRA, HPRA) related to MES systems
Program Delivery & Stakeholder Management
- Lead multi-site, global pharmaceutical MES programs
- Interface with:
- Manufacturing & Operations
- Quality, Validation & Compliance
- Automation & IT
- Mentor MES teams and provide technical governance
Mandatory Skills & Experience
Non‑Negotiable Requirements
- 15+ years of experience in MES / Manufacturing IT / Automation
- Mandatory pharmaceutical / life sciences industry experience
- Hands-on expertise in Aspen APEM for pharma manufacturing
- Proven experience delivering validated MES systems
- Strong GMP, GxP, CSV, and regulatory knowledge
Technical Skills
- Deep expertise in:
- Aspen Production Execution Manager (APEM)
- Electronic Batch Records (EBR)
- Batch process modeling & execution
- Integration experience with SAP, DCS, PLCs, historians
- Working knowledge of SQL, .NET, VB, Lua (preferred)
Soft Skills & Leadership
- Strong client-facing leadership in pharma environments
- Excellent communication with Quality, Manufacturing, and IT stakeholders
- Ability to lead global teams and standardization initiatives
Education
- Bachelor's or Master's degree in:
- Engineering (Automation / Chemical / Electrical / Computer)
- Computer Science / IT
- Life Sciences
