Job Title: Process Engineer
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Position Summary:
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The Process Engineer will report to the Manufacturing Operations Manager and be responsible for all activities associated with their assigned product steps.
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The overarching goal is to provide technical support within operations to meet agreed operational targets for safety, quality and customer delivery performance.
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The incumbent will execute restart activities to ensure that all new APIs manufactured at the site are adequately supported in line with policies and global SOP requirements.
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Responsibilities:
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1. Ensure manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.
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2. Technical transfer, scale-up and installation of new processes and unit operations onto and within the plant.
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3. Support process and facility start-ups, initial campaigns and process optimizations.
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4. Complete detailed equipment and process assessments.
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5. Project management of wide scope cross-functional projects.
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6. Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.
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7. Ensure campaign preparations for individual processes are achieved to facilitate on-time campaign start-up and adherence of agreed production rate.
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8. Takes ownership for assigned process steps and provide process technical support as required.
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9. Lead cross-functional investigations within operations.
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10. Use lean six sigma tools to drive root cause analysis and CAPA completion.
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11. The preparation and routine review of batch records, cleaning procedures, equipment operating procedures, standard operating procedures, protocols and summary reports.
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12. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.
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13. The development and update of control system recipes.
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14. Participation in audits, quality monitoring inspections and self-inspections as required.
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15. Participation and driving of Continuous Improvement Activities - including the continuous development and improvement of documentation, standards and processes.
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16. Lead cycle time reduction initiatives.
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17. Drive EHS activities within operations including participation in process HAZOP or wider safety initiatives.
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18. Preparation of change control packages (including those for international and US markets).
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19. Liaise with site engineering for equipment/control system modification/installation.
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20. System Owner/Subsystem Owner Responsibilities:
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System owners have overall accountability for the site quality systems for which they are responsible and in particular for:
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21. Providing strategic and proactive direction with respect to the system across the site in terms of content and execution.
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22. Providing support, guidance and coaching to subsystem owners.
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23. Ensuring that subsystem owners regularly review sub-systems for their effectiveness, escalating issues where required to site quality council (QRC) for action and remediation.
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24. Owning relevant system issues in the site compliance plan.
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25. Defining resources as needed and communicating resource needs to site lead.
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26. Applying people change control across subsystems within their responsibility.
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27. Ensuring that subsystem owners have proactive continuous improvement plans for their subsystems.
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28. Subsystem owners have overall accountability for the site quality subsystems for which they are responsible and in particular for:
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29. Providing strategic and proactive direction with respect to their subsystem across the site in terms of content and execution.
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30. Regularly reviewing their subsystem and presenting subsystem review to quality council (QRC) as required.
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31. Escalating issues where required to the system owner and site QRC for action and remediation.
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32. Owning relevant subsystem issues in the site compliance plan.
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33. Defining resources as needed and communicating resource needs to SO.
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34. Developing and implementing proactive continuous improvement plans for their subsystem.
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35. In partnership with the SO, ensuring that there are clearly defined experts for each subsystem, acting as a point of contact during inspections.
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36. Overseeing all documents associated with their subsystem and providing input to the document owners during updates.
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37. Providing comments on new/revised draft policies and guidelines and completing impact assessments where required.
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38. Organizational Relationships:
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Experience: 3-5 years experience in a technical role in the API industry. Education: Degree in Chemical/Process Engineering or Chemistry.
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Technical Skills and Competencies Required:
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39. Strong leadership, communication, decision-making and problem-solving skills.
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40. Experience with 6 sigma or other operational excellence tools.
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41. Experience of working in a cross-functional team in a highly regulated environment.
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42. Experience of technology transfer and a new product/equipment start-up.
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43. An understanding of computer control systems, P.I.D loops and interlock devices.
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44. Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectives.
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45. Physical Position Requirements:
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This is Rathdrum site-based position.
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This position will require fluent use of teleconferencing and WebEx tools, as well as SharePoint technologies, to share and manage information with Global GMS and other Zoetis internal API manufacturing network.
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Benefits:
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Competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working.
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Additional Requirements:
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Incumbent may be asked to perform other duties as required. Additional position-specific requirements/responsibilities are contained in approved training curricula.
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Colleague must be legally eligible to live and work in Ireland.
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Keyword: ProcessEngineer