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Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks, and labs in more than 120 countries, Ortho’s high-quality products and services enable healthcare professionals to make better-informed treatment decisions.
The Career Potential:
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
Accountable to the Shift Engineer to provide engineering support to manufacturing value streams and site equipment assets. The type of engineering support required would consist of equipment maintenance repair & overall, ensuring all service & calibration checks are performed for the specified machines.
Maximising Process Equipment Availability
- Maintain equipment compliance via the equipment management database, ‘Maximo’. Ensure all equipment reporting fields are rigorously followed and updated with concise, detailed information. All equipment breakdown interventions and recoveries are captured and updated to ‘Maximo’. Root cause must be established following the 6 questions of RCI.
- Continuous improvement of routine maintenance procedures and service contract activities.
- Facilitate teams carrying out Failure Modes Effects & Criticality Analysis (FMECA), Reliability Centered Maintenance (RCM) and Total Productive Maintenance (TPM).
- Plan, organize and undertake programs of work to improve equipment performance & uptime. Routinely communicate this activity to operational stake holders.
- Plan, organize and undertake service, calibration & repair of defined equipment for use at Ortho Pencoed
- Management of service contractors during their site activities.
- Ensure all routine service & calibration checks are performed for specified equipment.
- Ensure all test equipment used is calibrated and appropriate records maintained.
- Provide reports and documentation to ensure that service history & performance of defined equipment and instruments are traceable.
- Support departmental heads in engineering workshop (Including tool management), HSE & 5’s improvement initiatives.
Maximising Process Equipment Performance
- Develop machine performance metrics, which are linked to the site goals.
- By analysis of this data and selection of the appropriate tool(s) ensure that the equipment is operating at level, which will enable the value stream to achieve its MPS goals.
- Accountability & Ownership of the designated value stream process equipment in order to identify improvement opportunities.
- Identify and eliminate waste attributed to poor process equipment performance (through incremental process improvement projects, such as quality circles).
- Setup and lead maintenance board & calibration sticker audits within the value center or site as required.
- Provide reasonable overtime support to effectively resolve both operational and non-operational equipment issues.
- Provide the necessary support to ensure a reasonable and effective engineering ‘On-Call’ Rota is established and maintained.
- Provide effective cover for Peer Engineers to accommodate holidays, off-site activates, etc. Generation of documentation to maintain the validated state (Training, SOP’s).
- Technical Capability – Intellectual capacity, experience and training to function across engineering discipline boundaries to execute planned work and lead problems resolution.
- Appropriate Knowledge of Quality Management System and GxP requirements Strong business acumen and financial awareness.
- Health, Safety and Environment system requirements.
- Functional Business Acumen – appreciates Production demands and impact on own priorities and deliverables
- Problem Solving – Ability to lead/contribute to structured problem solving and Credo based decision making skills
- Communication – Uses appropriate tools and techniques to communicate at all levels of the business.
- Knowledge of Ortho franchise organization and products
- Knowledge of relevant functional requirements of Engineering group.
- Knowledge of PEx and Lean principles.
- Competently uses a range of modern office equipment and associated software.
- Minimum 3 years experience in a similar role ideally within the Pharma. or Diagnostic/Healthcare industry.
- Proven excellent track record of Engineering Maintenance within a highly regulated manufacturing environment.
- Proven ability to effectively work in cross-functional project teams.
Specific Technical Skills
- Good working knowledge of Microsoft office tools for communication and reporting
- Proven track record of process equipment implementation within a regulated environment
- Structured problem solving methodologies
- Working knowledge of project schedule software (e.g MS Project).
- Documentation / Technical report writing skills
- Six Sigma Green
- Lean Methodologies knowledge
- GAMP Knowledge
- Positive attitude
- Accepting of change
- Flexible - Calmly reacts to the unexpected.
- Strength of convictions – Will not accept second best
- Credible – Accountable for decisions
- Self Motivation
- Results focused
- Innovation – lateral thought
- Organized – Able to cope with extensive documentation and project planning requirements
- Honest and open
- Maintains high standards – for self
At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.