Cleaning Validation Engineer

3 weeks ago

Carlow, Ireland Quanta Consultancy Services Ltd Full time

Overview

Cleaning Validation Engineer - Ireland, Carlow - 11 Month Contract. Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, 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.

Essential Duties and 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.
- 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.
- 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.

Desirable Experience

- 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.
- 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.

If this role is of interest to you, please apply now

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