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 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