Manufacturing Validation Specialist

4 days ago


The Municipal District of Carlow, Ireland LSC, Life Science Consultants Full time
Job Description:

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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