An exciting opportunity for an experienced Process Engineer to join a leading manufacturing company based in Cork on a 12-month contract.
The Process Engineer (Aseptic filling process) is responsible for supporting the site manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE). He / she will also be responsible for the management of small / medium process improvement projects within the sites aseptic filling manufacturing areas.
Perform troubleshooting of issues identified during operations.
Lead manufacturing investigations, CAPA’s and Change Controls and ownership of Deviations within the sites Quality System (Trackwise).
Collation and Analysis of manufacture performance data to help focus improvement efforts. - Eg. Pareto, FMEA, DOE, 8D, 5-Why, Root Cause Analysis
Provide technical leadership by acting as ‘System Owner’ to drive improvements and excellence within specific aspects of the manufacturing operation.
Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
Aid and/or support maintenance, engineering, quality, or other colleagues as required.
Assist / Lead Facility and Equipment Validation activities.
Execution of Continuous improvement projects within the sites aseptic filling manufacturing areas.
Work closely with the technical operations manager to define, prioritise, and develop projects plans, including setting deadlines, prioritizing tasks, and deliverables.
Development and/or review of URS for process and automation systems. Lead and co-ordinate equipment vendor FATs ensuring acceptability of plant and documentation prior to site delivery.
Degree in Chemical Engineering, Process Engineering or associated Discipline.
Significant engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging and Devices.
Ability to read/interpret engineering drawings and design documents.
Excellent technical writing and verbal communication skills.
Good technical knowledge of project engineering principles i.e. all phases of project life cycle - URS through to hand-over.
Fluent in the needs of validation FAT to PQ (protocol generation, review, execution and reporting).
Knowledge of cGMP/GAMP requirements.
Experience with Six Sigma and Lean Manufacturing methods would be an advantage.
For a confidential discussion and more information on the role, please contact Barry O'Brien.