This is an 11 month maternity contract
Role will be shift 24/7 (7 to 7) with 33.33% shift allowance
• Serve as Technical Support for commercial manufacturing and new product introduction.
• Product Risk management and quality risk management Product SME.
• Management of change.
• 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/qualification validation programs; including re-qualification and re-validation.
• 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.
• Statistical data analysis to support development and commercialisation batches.
• 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.
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of the Company’s Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline.
• 5+ years minimum experience, typically have prior related work experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Lean Six Sigma Methodology experience desired.
• Data analysis experience required.
• Vendor liaison.
• Strong influencing skills.
• Flexible approach.
• Effective time management and multi-tasking skills.
• Excellent attention to detail.
• Trouble shooting skills.
• Data Analysis.
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