Lifescience Consultants has a contract opportunity for a Validation Engineer to join a global Biopharmaceutical company.
About the Role
This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including oncology, autoimmunity, pneumonia, and infectious disease.
Responsibilities
* Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Design, author, review, approve, and 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 notifications 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.
Requirements
To excel in this role, you will need:
* Experience in cleaning validation including CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimization, 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, operating as an individual contributor adding value to the business in a GMP manufacturing setting.
* Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* A proven track record in delivering excellence.
* Exception/Deviation Management and Change Control.
Note: You must be eligible to work in Ireland. A Stamp 1 G/Stamp 4 visa is required for this contract opportunity.