R&D Automation Engineer

  • Cork
  • Permanent
  • JO-1907-64643_1567509622

Summary

Job Title: R&D Project Engineer (Automation)

Reports to (Job Title): R&D Design Transfer Manager

Responsibilities:

· Leads and takes ownership for the implementation of high technology equipment. Product and/or processes for the production, finishing and inspection of IOLs and delivery system products.

· Support the integration of new products/process and suppliers into the existing manufacturing processes and/or product portfolio at Alcon Ireland.

· Manage equipment and process validations under the Quality system change control process

· To manage projects in which there is a significant automation / software component.

· Initiate change controls, validation and risk documentation within the quality system as required for new product design transfer equipment, materials, process improvements and new product implementation.

· Responsible for equipment / CS documentation development and approvals e.g. URS, FDS, FAT, SAT, IQOQPQ.

· Support cross functional design transfer project teams to ensure successful implementation of assigned project deliverables

· To develop and manage design transfer projects in which there is a major software component. This includes management and development of all change control deliverables.

· Responsible for ensuring all projects are completed to agreed timelines and within budget.

· Generate safety risk assessments for any new equipment and /or processes introduced to the manufacturing facility.

· Ensure seamless transition of new equipment. processes and products to the MTO and QA functions in Alcon Ireland.

· Assigned work adheres to H&S and environmental requirements.

Requirements:

· Degree in Engineering or related discipline

· 3-5 years' experience in Automation within a manufacturing environment working in a GAMP / regulated industry environment

· Knowledge of ISO, FDA, GMP standards.

· Strong background in Operating Systems, SCADA, PLC, SQL Server.

· A good understanding of GAMP 5 and 21 CFR Part 11 requirements

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