Manufacturing System Project Manager

Business Platforms

Cork

On-site

EUR 90,000 - 130,000

Full time

11 days ago
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Job summary

Business Platforms in Cork, Ireland seeks an experienced MES Project Manager to lead end-to-end MES implementation, enhancement and support within our manufacturing operations. You will manage cross-functional teams, ensure compliance with GMP/GxP, FDA 21 CFR Part 11 where relevant, and align MES initiatives with business goals across IT, QA and operations.

Required: 5+ years in MES deployment, a Bachelor’s degree in a related field, and familiarity with Emerson Syncade, Korber PAS-X, Rockwell

Qualifications

  • Bachelor’s degree in CS/Engineering/Life Sciences or related field.
  • 5+ years in MES deployment/implementation.
  • Strong knowledge of GMP/GxP and regulatory requirements.
  • Experience with Agile/Waterfall/Hybrid project methodologies.
  • Familiarity with MES platforms: Syncade, PAS-X, Pharmasuite, Opcenter.

Responsibilities

  • Lead MES implementation projects within budget, time and scope.
  • Develop project plans, risk assessments and resource strategies.
  • Coordinate with stakeholders, IT, vendors and system integrators.
  • Ensure MES aligns with ERP/SCADA and regulatory requirements.

Skills

MES project management
Regulatory compliance
Cross-functional leadership
Life sciences experience

Education

Bachelor’s degree in CS/Engineering/Life Sciences

Tools

Emerson Syncade
Korber PAS-X
Rockwell Pharmasuite
Siemens Opcenter
ERP integration

Job description

About Business Platforms

Headquartered in Cork, Ireland Business Platforms specializes in Manufacturing Execution Systems (MES), Serialization and Supply Chain Operations.


We provide consulting services globally in Strategy Development and Execution, Business Process Analysis and Design, Change Management, Validation, Implementation and Support to the Pharmaceutical Industry.


As a company we partner with our clients, to provide expertise and industry best practice to create and enable business value.


Job Title: MES Project Manager

Location: Cork, Ireland

Role Summary

The MES Project Manager will be responsible for the end-to-end implementation, enhancement, and support of the Manufacturing Execution System (MES) within our manufacturing operations. The role involves managing cross-functional teams, ensuring compliance with industry regulations, and aligning MES initiatives with business goals.


Key Responsibilities

Project Management


  • Lead MES implementation projects, ensuring timely delivery, within budget, and scope.

  • Develop and maintain project plans, risk assessments, and resource management strategies.

  • Coordinate between business stakeholders, IT teams, vendors, and system integrators.

  • Ensure project adherence to GxP, FDA 21 CFR Part 11, and other regulatory requirements.


MES Implementation & Support


  • Oversee MES design, configuration, testing, validation, and deployment.

  • Work closely with manufacturing, quality, and IT teams to ensure seamless integration with ERP, SCADA, and other systems.

  • Drive process optimization by leveraging MES functionalities such as electronic batch records (EBR), workflow automation, and real-time data capture.


Stakeholder & Change Management


  • Act as the primary point of contact between IT, operations, and regulatory teams.

  • Conduct training and change management initiatives to ensure smooth MES adoption.

  • Facilitate workshops and discussions to define business requirements and system enhancements.


Regulatory & Compliance


  • Ensure MES solutions comply with GMP, GxP, FDA 21 CFR Part 11, and ISO 13485 standards.

  • Work closely with Quality Assurance to support system validation and audits.

  • Maintain project documentation in alignment with regulatory requirements.


Qualifications & Experience


  • Bachelor’s degree in computer science, Engineering, Life Sciences, or a related field.

  • 5+ years of experience in MES implementation, preferably in the life sciences industry.

  • Strong knowledge of GMP, GxP, and compliance regulations.

  • Experience managing projects using Agile, Waterfall, or Hybrid methodologies.

  • Familiarity with MES platforms such as Emerson Syncade, Korber PAS-X, Rockwell Pharmasuite or Siemens Opcenter.

  • Experience integrating MES with ERP (SAP, Oracle), SCADA, LIMS, and data historian.

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