Manufacturing Execution Systems (MES) Engineer

Overview

Remote
Depends on Experience
Accepts corp to corp applications
Contract - W2

Skills

Conflict Resolution
Analytical Skill
Break/Fix
Change Management
Collaboration
Manufacturing
GMP
HP ALM
Lifecycle Management
MES
Management
Manufacturing Execution System
Communication
Continuous Improvement
Documentation
Durable Skills
Pharmaceutics
Problem Solving
Process Modeling
Process Optimization
Regulatory Compliance
English
Manufacturing Operations
Master Control
OQ
Offshoring
IQ
Root Cause Analysis
Software Design
Specification Gathering
Testing
Training

Job Details

About the Role:

We are seeking a skilled MES Engineer to join our team, where you ll work closely with the Global IT organization and site stakeholders to understand and address critical business needs in Pharmaceutical/Biotech manufacturing environments. You ll play a key role in designing, implementing, validating, and supporting cutting-edge MES (Manufacturing Execution System) solutions, ensuring systems remain compliant and deliver meaningful value to operations.

Key Responsibilities:

  • Collaborate with Global IT and site teams to gather and interpret business requirements and deliver tailored MES solutions.

  • Design, configure, and manage Production Procedures using tools such as PMX, Syncade, and MasterControl.

  • Conduct end-to-end testing and validation of Electronic Batch Records (EBR) using HP ALM.

  • Facilitate process review meetings with business stakeholders to ensure alignment and requirement accuracy.

  • Validate Production Procedure Tickets for regulatory compliance and operational integrity.

  • Define and implement technical requirements, selecting suitable applications, platforms, and architectures.

  • Translate functional business needs into detailed technical specifications.

  • Investigate and resolve complex MES issues through root cause analysis, break-fix testing, and change management processes.

  • Maintain thorough documentation for project deliverables and technical solutions.

  • Collaborate effectively with onshore and offshore technical teams, sharing relevant information and updates.

  • Support training initiatives and contribute to the development of user procedures and operational guidelines.

  • Ensure all MES implementations adhere to internal quality standards and regulatory requirements (GMP).

  • Promote adherence to technology best practices and support continuous improvement initiatives.

Essential Skills:

  • Demonstrated experience troubleshooting and supporting MES platforms such as PharmaSuite, PMX, or Syncade.

  • Strong knowledge of IT system lifecycle management, business process modeling, and the ISA-95 standard.

  • Excellent written and verbal communication skills in English.

  • Analytical mindset with strong problem-solving and process optimization abilities.

  • Ability to execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols and author comprehensive validation documentation.

  • Solid understanding of Pharmaceutical/Biotech manufacturing operations and systems.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.