Overview
Cleaning Validation Engineer - Ireland, Carlow - 11 Month Contract
Do 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 Function
* Quality 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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