Technical Consultant MES ASPEN

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

Role Overview

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 endtoend 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 ISA88 / ISA95 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

NonNegotiable 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 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

• Bachelors or Masters degree in:
• Engineering (Automation / Chemical / Electrical / Computer)
• Computer Science / IT
• Life Sciences