JOB DESCRIPTION SUMMARY

As a Principal Engineer at GE Healthcare Ireland Limited, you will play a pivotal role in leading and shaping the technical direction of our engineering projects. You will be responsible for overseeing the design, development, and implementation of complex engineering solutions, ensuring they meet the highest standards of quality and performance. Your expertise will be crucial in driving innovation and excellence within our engineering team, particularly in the area of operational engineering for large capital projects.

QUALIFICATIONS AND REQUIREMENTS

• Degree in Chemical Engineering, Process Engineering, or associated discipline or equivalent
• 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.

Safety Mindset

• Proactive awareness, regularly assess risks and take preventive measures to mitigate potential hazards.
• Compliance and standards adhere to all safety regulations and ensure team members follow safety protocols.
• Communication, foster open communication about safety concerns and encourage reporting of hazards.
• Training and education, provide ongoing safety training and stay updated on the latest safety practices.

Technical Leadership:

• Lead and mentor a team of engineers, providing guidance and support to ensure successful project delivery.
• Represent operational engineering as the technical lead in large capital projects, ensuring alignment with project goals and objectives.
• Develop and maintain technical standards, best practices, and procedures to ensure consistency and quality across all engineering activities.

Project Management:

• Oversee the planning, execution, and delivery of engineering projects, ensuring they are completed on time and within budget.
• Collaborate with cross-functional teams to define project scope, objectives, and deliverables.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure successful outcomes.

Innovation and Continuous Improvement:

• Drive innovation within the engineering team, encouraging the exploration of new technologies and methodologies.
• Implement continuous improvement initiatives to enhance the efficiency and effectiveness of engineering processes.
• Stay up-to-date with industry trends and advancements, integrating relevant developments into project strategies.

Stakeholder Engagement:

• Build and maintain strong relationships with internal and external stakeholders, including clients, vendors, and regulatory bodies.
• Communicate technical concepts and project updates to non-technical stakeholders in a clear and concise manner.
• Represent the company at industry conferences, seminars, and other events, showcasing our engineering capabilities.

Operational Engineering:

• Lead the operational engineering efforts in large capital projects, ensuring seamless integration of operational requirements into project designs.
• Collaborate with project managers and other technical leads to ensure operational engineering considerations are addressed throughout the project lifecycle.
• Provide technical expertise and support during the commissioning and operational phases of projects.

Process Improvement:

• Perform troubleshooting of issues identified during operations.
• Lead manufacturing investigations, CAPA’s, Change Controls, and ownership of Deviations within the site’s Quality System (Trackwise).
• Collate and analyze manufacturing performance data to help focus improvement efforts using tools such as Pareto, FMEA, DOE, 8D, 5-Why, and Root Cause Analysis.
• Provide technical leadership by acting as ‘System Owner’ to drive improvements and excellence within specific aspects of the manufacturing operation.
• Support the 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.

Validation and Compliance:

• Assist and/or lead facility and equipment validation activities.
• Execute continuous improvement projects within the site’s aseptic filling manufacturing areas.
• Develop and/or review URS for process and automation systems. Lead and coordinate 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.
• Ensure adherence to standards and good engineering practices.

Investigations and Audits:

• Act as the engineering technical lead during investigations and audits, providing expert guidance and support.
• Lead the preparation and presentation of technical information during internal and external audits.
• Ensure all engineering activities comply with regulatory requirements and internal standards.