Biopharmaceutical Validation Expert

2 days ago


Carlow, Ireland Life Science Consultants (LSC) Full time

**Job Overview:**

We are seeking a skilled Validation Engineer to join our team at Life Science Consultants (LSC). As a global Biopharmaceutical company, we operate a state-of-the-art vaccines and biologics manufacturing facility in Carlow. Our team is responsible for ensuring the highest standards of quality and compliance in our operations.

In this role, you will be working on designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies in line with our standard approval process. You will also engage with Production, Maintenance, and Quality representatives to resolve technical issues encountered during study execution.

To excel in this role, you should have experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development, cleaning verification, cleanability, and recovery studies using TOC, ICP & swab methods. Considerable experience in a comparable role in a GMP manufacturing setting is required.

Additionally, you should possess relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification. A proven track record in delivering excellence and knowledge of Exception/Deviation Management and Change Control are also essential.

**Key Responsibilities:**

  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies
  • Engage with Production, Maintenance, and Quality representatives to resolve technical issues
  • Perform root cause analysis of system failures using standard tools and methods
  • Develop and execute cleaning validation protocols

Requirements:

  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers
  • Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
  • Proven track record in delivering excellence
  • Knowledge of Exception/Deviation Management and Change Control


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