This is a 9 month contract
Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.
• Serve as technical and/or validation support as required for manufacturing and new product introduction.
Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
Provide technical input into quality notification by authoring/reviewing/approving investigations.
Execution of equipment commissioning and qualification programs
Execution of equipment/qualification validation programs; including re-qualification and revalidation.
Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Support continuous improvement through Lean Six Sigma methodologies.
Leading and active participation in projects, system failure investigations and investigation reports.
Execution/development of change controls
Contribution to Kaizen events as appropriate.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,5 why’s etc.
Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• May be required to perform other duties as assigned.
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• A minimum of 5 years relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Sterile filling processes and equipment experience.
• Proficiency in Microsoft Office and job related computer applications required.
• Lean Six Sigma Methodology experience desired.
• Flexible approach.
• Effective time management and multi-tasking skills.
This is a shift position (24/7).
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