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This is an exciting opportunity for a fantastic Senior Engineering Specialist for candidates interested in a new challenge in a cGMP regulatory environment.
The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.
Role Functions Bring energy, knowledge, innovation to carry out the following: Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
Design/Author/Review/Approve/Execute Execution/development of change controls.
Resolving technical issues encountered during study execution.
Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
Technical input into quality notification by authoring/reviewing/approving investigations.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
Support continuous improvement through Lean Six Sigma methodologies.
Serve as validation representative for cross functional projects and represent the validation team at global technical forums Drive compliance of Global 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 actions, participation in audits and inspections and proactively highlighting any issues around compliance Supporting regulatory audits and submissions as required.
Work collaboratively to drive a safe and compliant culture in Carlow.
May be required to perform other duties as assigned.
Skills Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
Exception / Deviation Management and Change Control.
Demonstratable experience of leading technical related projects.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable Evidence of continuous professional development is desirable.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
Report, standards, policy writing skills required.
Equipment and process validation.
Sterile Fill-Finish processes and equipment.
Proficiency in Microsoft Office and job-related computer applications Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Experience Filter Validation CCI qualification Shipping Qualification Equipment Periodic Validation Equipment Validation Lifecycle Project Management Skills/Qualification Autoclave/SIP Sterilisation Validation Dry Heat Sterilisation Isolator VHP/HVAC Qualification Controlled Temperature Units/Equipment Qualification Vial and Syringe Processing Technologies Qualifications & Education Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification Skills: cleaning validation fill finish execution team