Manufacturing Validation Specialist
4 days ago
LSC, Life Science Consultants has a great contract opportunity for a Validation Engineer III to join a global Biopharmaceutical company in Carlow.
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/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.
Requirements:
To excel in this role, you will need:
- 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, as well as the following qualifications/skills:
- 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.
- Exception / Deviation Management and Change Control.
Advantageous Skills:
Knowledge and experience of the below areas will be considered advantageous:
- Filter Validation
- Shipping Qualification
- Equipment Periodic Validation
- Isolator VHP/HVAC Qualification
- Controlled Temperature Units/Equipment Qualification
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