OverviewCleaning Validation Engineer - Ireland, Carlow - 11 Month ContractDo you want to be involved with exciting pharmaceutical projects? Our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Cleaning Validation Engineer.Responsibilities
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.
Resolve technical issues encountered during study execution.
Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
Provide technical input into quality investigations by authoring/reviewing/approving investigations.
Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Be accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance.
Support 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.
Desirable Experience
Experience in cleaning validation including 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 GMP manufacturing role, adding value as an individual contributor.
Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification; proven track record in delivering excellence.
Qualifications
Demonstrated ability to work in a GMP manufacturing environment.
Strong technical writing, documentation and investigation skills.
Ability to collaborate with cross-functional teams and participate in audits.
Job FunctionQuality Assurance
Note: This job description retains the essential duties and responsibilities of the role and does not imply any guarantees of employment terms.
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