GE HealthCare Technical Operations & Optimization Lead 

Ireland, Cork 

846284056

DSCRIPTON:

This job specification outlines the general responsibilities associated with the role of Technical Operations & Optimization on the GE Healthcare Cork Site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. We are seeking a dynamic and experienced Technical Operations and Process Optimization Manager to play a crucial role in driving operational excellence and engineering compliance within our organization. This multifaceted position will require a strategic thinker with strong leadership skills and a keen eye for process improvement opportunities. The successful candidate will lead initiatives across validation, process engineering, sterility assurance, asset reliability, and engineering compliance to ensure the highest standards of quality, efficiency, and regulatory compliance are met.

REPOTINGINE:

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MAINUIES AND RSONIBIES:

• Validation Management:Develop and execute validation comprehensive strategies and protocols for processes, equipment, and systems, ensuring compliance with regulatory requirements and industry best practices. Coordinate validation activities, including protocol development, execution, and documentation, to support product manufacturing and quality assurance activities.

• Process Engineering:

• Sterility Assurance:Establish and maintain robust sterility assurance programs to safeguard product integrity and patient safety in sterile manufacturing environments. Implement procedures for monitoring and controlling microbial contamination risks, including environmental monitoring, aseptic processing controls, and sterilization validation.

• Asset Reliability:Develop and implement asset reliability strategies to maximize equipment uptime, minimize unplanned downtime, and optimize asset performance across manufacturing facilities. Utilize reliability engineering principles, predictive maintenance techniques, and condition monitoring technologies to proactively manage equipment reliability and mitigate risks of equipment failure.

• Engineering Compliance:Support the development and adherence to Global and local engineering equipment standards, regulatory requirements, and quality management systems to maintain compliance with relevant regulations and standards. Collaborate with regulatory affairs and quality assurance teams to interpret and implement regulatory guidelines, standards, and directives related to validation, process engineering, and equipment compliance.

• Continuous Improvement:Drive a culture of continuous improvement by fostering innovation, encouraging employee engagement, and championing process optimization initiatives. Lead or support Lean Six Sigma projects, Kaizen events, and other improvement activities to drive measurable results and enhance operational performance.

• Risk Management:Identify, assess, and mitigate operational risks associated with validation, process engineering, sterility assurance, asset reliability, and engineering compliance. Develop risk management strategies and mitigation plans to proactively address potential threats to product quality, patient safety, and regulatory compliance.

Compance

• HS: Responsibility foremergencyprocedures, safety systems, safety performance,communication,and behaviorswithinthe department.

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• Play a leadershiprole inhealth, safetyandenvironmental issuesandteams.
• LeadEngineeringCAPAinvestigations, determiningaccuraterootcauseandimplementing action planstopreventreoccurrences.

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• Ensure the asset reliability developed and maintenance in alignment with ISO standards.

Teameasp and catyeveopment

• Team Leadership: lead, motivate and manage department personal anchored by the GE Beliefs to achieve required targets. Ensure effective delegation of tasks to the technician group.
• Responsible for developing people and technical capabilities and skills to maximize operational equipment uptime, implement new technologies and applying best practice in maintenance methods and systems.
• Efficient delegation and effective management of department personnel and their duties
• Negotiate change in work practices with the functional groups and stakeholders.
• Recruitment, training, retention & development of department engineering staff
• Act as an integral link in the communication process (monthly/weekly/Daily briefings)

calfiatos/sks adokxpce:

• Bachelor’s degree in engineering, science or a related field; advanced degree preferred.
• Proven experience in technical operations, process optimization, and compliance management within the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of regulatory requirements, including FDA, EMA, and other relevant authorities, pertaining to validation, process engineering, and sterility assurance.
• Experience with risk-based approaches to validation and process optimization, including FMEA and statistical analysis.
• Demonstrated people leadership skills with the ability to lead cross-functional teams and drive initiatives to successful completion.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making.
• Proven track record of implementing process improvements and driving operational excellence initiatives.
• Knowledge of asset reliability principles, including predictive maintenance strategies, is desirable.
• Certification in relevant areas such as Six Sigma, Lean Manufacturing, or Project Management is a plus.

ey Cmpetenciese:

• Patient centric leadership

• Results orientation
• Customer focus
• Leadership & Coaching
• Influencing skills
• Systems background
• Strong work ethic
• Communication skills
• Genuine interest in people
• Initiative
• Highly motivated