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: 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.