Project Engineer Contract
Job ID: JOB-11609
Project Engineer Contract
Our client a leading MNC is recruiting for a contracting Project Engineer to join their team in Mayo. This role is commutable from Sligo and Roscommon. The Project Engineer will lead the project team in upgrading legacy equipment (aseptic processes and or packaging equipment) whilst managing the completion of: change controls, risk assessments, integration protocols, test scripts and summary reports, SOP updates, user training, and equipment asset care activities where required.
- Develop project plans/budgets and interface with 3rd Party Vendors / Suppliers and stakeholder management fostering a collaborative approach to deliver the control / IT system legacy upgrade on time, to budget and to the expected regulatory standards.
- Maintain project plans/budgets and be proactive in seeking out opportunities and implementing risk management techniques to deliver the upgrade in a challenging and complex environment.
- Develop weekly and monthly reports for their respective legacy upgrades reporting directly into the Senior Project Manager and MSTU PMO
- Lead the project team in developing/promoting good practices to continuously improve the quality and effectiveness of the project lifecycle and associated processes to ensure consistency across the wider programme achieving expected outcomes and management of:
- Third Parties Quality Management
- Internal Control and Risk Management
- Predictive Compliance Planning and Remediation
- Weekly and Monthly dashboards
- Managing and ensuring timely Review & Approvals of SDLC documentation
Education, Experience and Skills required:
- A degree in Engineering, Computer Science, or related discipline / equivalent experience.
- A minimum of 4 years experience delivering complex automation projects in Pharmaceutical and/or Medical device industry.
- Fully conversant in delivering complex projects adopting waterfall and or agile project methodologies.
- Understanding of relevant GAMP and relevant EU/FDA regulations around software and data systems.
- Understanding of GxP and GDP practices, 21 CFR Part 11 and good working knowledge of Data Integrity
- Proven ability to work without direct supervision.
- Strong verbal and written communication skills.
- Proven experience delivering / managing / implementing change to complex manufacturing systems to support business-critical process equipment.
For further information on this Contracting Project Engineer role in Mayo please contact Deirdre Finnerty on 086 3073779/ firstname.lastname@example.org
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