Reliability Engineer with a focus on pharmaceutical packaging equipment performance and equipment lifecycle management. Involved in project management and ensuring compliance with safety regulations across PCI Pharma Services in Ireland.
Responsibilities
Analyse current processes to assess performance, identify improvement opportunities for equipment reliability, preventive and predictive maintenance, and condition monitoring
Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment / systems
Using SMED principles identify opportunities to improve the consistency and RFT of our batch change-over / machine setting activities
Assist the Project Engineering function with the transfer of new equipment from the validation to commercial phase of our NPI projects
Implement a critical spares program based on OEM specifications, ongoing maintenance programs and the predictive maintenance program
Ensure the calibration of all relevant engineering equipment is maintained appropriately
Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Work with the Continuous Improvement team and Department Managers to deliver operational excellence within PCI Ireland focusing on the warehouse functions
Design, implement, review and action critical KPIs for processing equipment
Requirements
Minimum of 5 years’ experience in a pharmaceutical, medical device or similar environment
Experience in change control, management of change, non-conformance, corrective and preventative actions and validation practices
Excellent communication skills, both verbal and written
Knowledge of pharmaceutical packaging equipment, packaging materials, technologies and challenges with each
Experience in a GMP or Regulated Environment
Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy
Ability to manage multiple tasks and set priorities
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