Technical Operations & Optimization Lead

at  GE Healthcare

JOB DESCRIPTION SUMMARY

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
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DESCRIPTION:

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.
This position is responsible for the management of the Technical Operations & Optimization team within the Engineering Department in line with routine operational and longer-term strategic plans.

PREFERRED QUALIFICATIONS

• Excellent Communication and interpersonal skills
• Experience in coaching, mentoring, and counselling.
• Knowledge of applicable regulatory guidelines
• Performance management skills and mentoring where required.
• Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.
• Budgeting and planning experience in an engineering function
• Experience in reliability and root cause analysis techniques i.e RCM, FMEA and equipment criticality assessments

Principal qualifications/skills and work experience required:

• 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

• 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: Lead cross-functional teams in identifying, analyzing, and optimizing operational processes to enhance efficiency, productivity, and cost-effectiveness. Utilize tools such as process mapping, data analysis, and root cause analysis to drive continuous improvement initiatives and streamline workflows.
• 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.
• Cross-functional Collaboration: Collaborate closely with local and global cross-functional teams, including manufacturing, quality assurance, regulatory affairs, supply chain, and R&D, to align operational activities with business objectives and ensure seamless execution of projects and initiatives. Serve as a subject matter expert and provide guidance on technical operations and process optimization matters.
• 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.

Compliance

• EHS: Responsibility for emergency procedures, safety systems, safety performance, communication, and behaviors within the department.
• Ensure all immediate safety and compliance activities are addressed in a timely and satisfactory manner.
• Ensuring that plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirement.
• Ensure that all health, safety & environmental requirements are fulfilled in accordance with the responsibilities defined in the company safety & environmental statements.
• Play a leadership role in health, safety and environmental issues and teams.
• Lead Engineering CAPA investigations, determining accurate root cause and implementing action plans to prevent reoccurrences.
• Ensure all Quality Track Wise actions that are assigned to the group are actioned and closed in a satisfactory manner.
• Ensure 5S standards are maintained and improved.
• Ensure the asset reliability developed and maintenance in alignment with ISO standards.

Team leadership and capability development

• 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)

  Principal qualifications/skills and work experience required:

• 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.

Key Competencies Required:

• 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