Our client is a bio pharmaceutical company based in East Cork looking for a Process Engineer (Aseptic filling process) to support the site manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE). 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.
- Manage project approval progress tracking, monthly reporting, and forecasting.
- Interface externally with external engineering consultants, major equipment vendors and Corporate Engineering.
- Play a key role in the review, approval and execution process of Engineering and Validation lifecycle documentation.
- Coach wider team on process knowledge, chemistry and build mastery among team.
- Remain current on state-of-the-art for systems, and for the appropriate adoption and use of new techniques and technology.
- Represent our client with outside firms, technical societies, standards organizations and regulatory bodies.
- Oversee the development, revision, review, and approval of Standard Operating Procedures that are owned by Technical Operations department.
- Ensure adherence to standards and good engineering practices.
Qualifications & Experience:
- 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.
- 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.
- Proficiency in the use of quality management systems, with experience in the use of Trackwise software being an advantage.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
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