Validation Engineer Contract Opportunity
We have an exciting contract opportunity for a skilled Validation Engineer to join our global Biopharmaceutical company in Carlow.
This state-of-the-art vaccines and biologics manufacturing facility produces products across various therapeutic areas, including oncology, autoimmunity, pneumonia, and infectious disease.
Key Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Develop and implement change controls, ensuring seamless execution.
* Resolve technical issues encountered during study execution, collaborating with Production, Maintenance, and Quality representatives as needed.
* Contribute to quality notifications by authoring, reviewing, and approving investigations.
* Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Requirements:
* Experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimization, cleaning verification, cleanability, and recovery studies.
* 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 of delivering excellence in a similar role.
* Exception/Deviation Management and Change Control expertise.
Desirable Skills:
* Filter Validation CCI qualification.
* Shipping Qualification.
* Equipment Periodic Validation.
* Isolator VHP/HVAC Qualification.
* Controlled Temperature Units/Equipment Qualification.