Job Title: R&D Project Engineer (Automation)
Reports to (Job Title): R&D Design Transfer Manager
· 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.
· 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
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists