Automation Project Engineer 1136
SimoTech require an Automation Project Engineer with 5 years’ experience to provide Automation expertise on a number of capital projects. The projects will involve a range of plant expansion and upgrades across our client site in Kildare. Previous experience on a Pharmaceutical or Life Sciences site is desirable.
- Manage project activities within the project team ensuring project objectives and deliverables are met.
- Participate among cross-functional teams to ensure projects are delivered on time and to required quality standards.
- Produce and manage the project strategy ensuring agreed objectives can be met Vendor management.
- Monitor activity progress for the project in line with the project objectives, deliverables and timelines and report potential delays including mitigation recommendations.
- Manage the project Risk Log ensuring all identified risks have been mitigated.
- Provide project reports on a regular basis for effective communication.
- Provide support for product costing and financial assessment of the project.
- Monitor project expenses in line with the approved project budget.
- Ensure smooth transfer of project knowledge and technology from engineering to production.
- Ensures all activities, equipment and facilities comply with site cGMP, Health, Safety and Environmental policies.
- Role will encompass, Scope development and approval, Scope change management, URS generation, Detailed design (FS/HDS/SDS review) and Executing, and reviewing commissioning and validation protocols.
- Knowledge of Computer System Validation (CSV) and regulations including, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Good communication and technical writing skills are a must.
- Demonstrated Analytical and problem-solving skills.
- Analyse, understand, fault-find and modify automation software.
- An ability to work independently.
- Ability to document own work clearly and precisely.
- Ability to organize, plan and execute multiple tasks to tight schedules.
- Project Management experience.
- Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences is desirable.
- Experience working on a Tabletting or Packaging plant would be an advantage.
- Strong knowledge of PLC/SCADA Systems, SQL & Oracle Database systems, MES, Batch & Historian systems, Enterprise IT Applications, Rockwell, Siemens, Wonderware, GE iFix.
- Good understanding of GAMP.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Long term project opportunity.
- SimoTech can facilitate these positions as a staff engineer or contract engineer.
- Competitive staff or contract rates.
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