Process / Equipment Engineer

1. General Information:     Job Title: Equipment/Process Engineer    Department: Technical Operations (Bio-Vaccine Suites)   Position Reports to: Plant Engineering Lead   Type: Permanent Secondment     2. Job Purpose     Provide process engineering/technical support to support the ongoing requirements of the Bio-Vaccines Suites. The process engineer is responsible for providing support to the operating unit ensuring that the equipment is robust, reliable and all issues are resolved to support the effective and efficient manufacture and disposition of product .   3. Job Responsibilities:    Equipment and Process Support:   • Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.  • Lead Method 1's to determine root cause and implement corrective actions.  • Lead investigations for equipment and process related issues, providing product/process impact assessments, appropriate root cause analysis and effective CAPA implementation.  • Provide equipment technical support/troubleshooting and implement process/equipment CAPA’s and improvements.  • Support the shift engineering teams with routine technical support and troubleshooting.    Validation and compliance:   • Generate and implement documentation for cGMP re-validation and periodic review of systems, equipment and manufacturing processes including Annual Re-Validation Plans and Risk Assessments and IQ/OQ/PQ/QV Protocols and Reports to ensure equipment remains validated  • Provide technical expertise during audits and also to present & defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required.  • Perform, execute and close out the annual periodic review programme for recently qualified equipment.    Continuous Improvement:   • Use Integrated Manufacturing Excellence (IMEx) and the Digital Operations Centre (DOC) to drive success in the Safety, Quality, Supply, Finance and People metrics.  • Identify process & equipment improvements, safety initiatives and develop these into Continuous Improvement (CI) projects.  • Work to implement a culture of Right-First Time and Zero Defects through partnerships with Operations and Core Engineering and Core Technical Services.  • Represent Tech Ops Process Engineering for the Eqpt. Reliability Programme. Highlight equipment reliability concerns / Spare Parts Obsolescence concerns.    Capital Projects:   • Represent Tech Ops Process Engineering on Capital Project teams where responsibilities would include SME technical input / End User requirements input.    4. Education & Experience     • Third level Qualification in Science, Engineering or equivalent is preferred, though not essential.  Exceptions may be considered where relevant skills, experience, and application exist (this may be supplemented by further education in parallel).   • 3-5 years’ experience in the Industry, preferably Biopharmaceutical/pharmaceutical.  • Experience and working knowledge of validation/revalidation systems.  • Excellent communication and interpersonal skills and an ability to work independently and in a fast paced, dynamic environment.  • Experience working with the compliance systems eQMS and QTS or similar.  • Working knowledge of MCS and PI.  • Experience of regulatory inspections.  • This job description indicates the general nature and level of work expected of the incumbent.  It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent.  Incumbents may be asked to perform other duties as required.    Work Location Assignment: Hybrid  All applicants must have relevant authorisation to live and work in Ireland.