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MES EBR Engineer
Wicklow, Ireland
Oleson is a technology strategy and transformation practice specializing in IT/OT systems in manufacturing operations, with a focus on regulated life sciences manufacturing. Our expertise lies in taking a comprehensive system view and understanding the interconnectedness of manufacturing operations, business continuity, IT infrastructure, compliance and change control, and system lifecycle planning. We offer strategic advice and implementation services to ensure that your IT/OT systems directly drive your business needs, and we have extensive experience in complex capital projects in manufacturing operations.
Role Description
We are currently looking for an experienced MES/EBR design professional to join our team. Reporting to the IT & Data manager you will be responsible for development of a comprehensive EBR system for end-to-end pharmaceutical production. You will play a key role in system design, implementation and support of the system on site. This is a Hybrid role, with 3 days required on site.
- Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
- To lead and/or support validation projects and activities on site, as directed and as appropriate.
- To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.
- Commissioning and validation of various new processes, technologies and new equipment.
- Creation, review and approval of various quality documents and test data.
- Management of validation exception events and change control processes.
- To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
- Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
- Generation of validation investigations and implementation of corrective actions.
- Providing continuous improvement for existing validation procedures.
- Lead the planning, execution, and delivery of MES/EBR implementation projects in alignment with the client’s business objectives and timelines.
- Collaborate with cross-functional teams, including IT, engineering, operations, and quality assurance, to ensure successful project execution.
- Define project scope, goals, and deliverables, and develop detailed project plans to monitor and track progress.
- Validation of Computer systems in line with regulatory requirements.
- Conduct risk assessments and implement mitigation strategies to address potential project risks and issues.
- Facilitate communication and collaboration between stakeholders at all levels of the organisation to ensure project alignment and success.
- Provide regular project status updates and reports to key stakeholders, including senior leadership and executive management.
- Ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.
- Support change management activities, including training, documentation, and stakeholder engagement, to facilitate the successful adoption of MES solutions.
- Third level qualification in Information Technology or Scientific discipline.
- 3+ Years experience in design and implementation of MES projects within a Pharmaceutical or Life science industry.
- Strong understanding of Manufacturing Execution Systems (MES) and related technologies, such as SCADA, DCS, and PLC interfaces.
- Demonstrated leadership skills with the ability to lead cross-functional project teams and drive results in a matrixed organisation.
- Excellent communication, interpersonal, and stakeholder management skills.
To find out more about what we do visit our website here – https://oleson.io/
Salary
TBC
Don’t worry if there isn’t a current opportunity that suits your own expertise and interests. Positions arise with us for experienced
professionals on an ongoing basis. To register your interest for future roles that arise within our team, please email recruitment@oleson.io