Join to apply for the Validation Engineer III role at LSC, Life Science Consultants.
LSC has a great contract opportunity for a Validation Engineer to join a global Biopharmaceutical company in Carlow. This state-of-the-art vaccines and biologics manufacturing facility is currently producing products in various therapeutic areas including oncology, autoimmunity, pneumonia, and infectious diseases.
Responsibilities:
1. Design, author, review, approve, and execute qualification and validation documentation, as well as cycle development studies, in line with standard approval processes.
2. Design, author, review, approve, and execute change controls.
3. Resolve technical issues encountered during study execution.
4. Engage with Production, Maintenance, and Quality teams during Cycle Development & Performance Qualification activities.
5. Contribute technical input into quality notifications by authoring, reviewing, and approving investigations.
6. Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Qualifications and Experience:
1. Experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development, verification, cleanability, and recovery studies using TOC, ICP, and swab methods.
2. Significant experience in a GMP manufacturing setting, operating as an individual contributor adding value to the business.
3. Relevant technical qualification(s) in Applied Pharmaceutical, Biological, Chemical sciences, or Engineering.
4. Experience with deviation management and change control.
Additional Knowledge (Advantageous):
* Filter validation
* Shipping qualification
* Equipment periodic validation
* Isolator VHP/HVAC qualification
* Controlled temperature units/equipment qualification
Additional Notes:
Applicants must be eligible to work in Ireland and hold a Stamp 1G/Stamp 4 visa for this contract opportunity.
Apply via this advert or contact Sarah Ninan at 0214777329 for more questions about this opportunity.
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