GE Healthcare, Cork
GE Healthcare Ireland Limited manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE Healthcare, we support the PDx vision of being the best in class supply chain delivering the right dose to the right patient at the right time.
Here at our campus at Carrigtohill, Co. Cork, we employ ~600 staff and are a 24/7 operation exporting to 93 markets worldwide. Every second of every day, 365 days a year, a patient is diagnosed with the help of our products through procedures such as X-Ray and MRI. We are a modern, agile, cost competitive team delivering to the highest standards of safety, quality and compliance to patients around the world and are on a transformation journey to double our capacity over the next 5 years.
We improve lives in the moments that matter…
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,
The candidate will have knowledge and proficiency in the use of statistical analysis tools, project management methodologies, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and associated Process automated systems.
MAIN DUTIES AND RESPONSIBILITIES:
- 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
- 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 within GE Healthcare.
- Represent GE Healthcare 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.
- Use their network to provide engineering support to the commissioning team, to resolve escalated technical issues and conflicts, as required.
DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.
PRINCIPAL QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:
- 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
- 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
- Strong problem solving and decision-making skills and attention to detail
- Strong interpersonal skills and the ability to communicate across functions.
- Ability to manage time independently, tasked with short term reactionary duties as well as long term strategic projects
Relocation Assistance Provided: No