Manufacturing Execution Systems (MES) Engineer

Manufacturing Execution Systems (MES) Engineer

Posted 7 days ago by 1751463550

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Negotiable
Outside
Remote
USA
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Application Lifecycle Management Business Process Business Process Modeling Business Requirements Change Management Lifecycle Management Management Management Process Process Modeling Process Optimisation Root Cause Analysis Stakeholder Management System Lifecycle Verification And Validation

Summary: We are seeking a skilled MES Engineer to collaborate with the Global IT organization and site stakeholders in Pharmaceutical/Biotech manufacturing environments. The role involves designing, implementing, validating, and supporting MES solutions to ensure compliance and operational value. The engineer will also troubleshoot complex MES issues and maintain thorough documentation. This position is remote and classified as outside IR35.

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.

Key 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.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: IT

Detailed Description From Employer:

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.

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