Validation Professional

2 days ago


Dublin, Dublin City, Ireland beBeePharmaceutical Full time €60,000 - €80,000

Job Title: Validation Specialist

Cleanliness Matters

We are seeking a skilled Validation Specialist to join our team in a contract role.

The successful candidate will be responsible for supporting cleaning validation including recovery and cleanability studies.

Key Responsibilities:

  • Design, author, review, approve, and execute qualification and validation documentation and cycle development studies in line with the standard approval process.
  • Design, author, review, approve, and execute execution and 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 and performance qualification activities.
  • Technical input into quality notifications by authoring, reviewing, and approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.

Requirements:


Essential Skills and Qualifications:

  • Experience in cleaning validation, including but not limited to CD and PQ of mobile vessels (CIP) and parts washers (COP), including recipe development and optimisation, cleaning verification, cleanability, and recovery studies using TOC, ICP, and swab methods, acceptable residual limit determination, worst-case soil matrices, and strategy development.
  • Considerable experience in a comparable role, with experience 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, with a proven track record in delivering excellence.
  • Exception/deviation management and change control.
  • Demonstratable experience of leading technical-related projects.

Benefits:


A Competitive Package:

Our client offers a competitive remuneration package that reflects the skills and expertise of the successful candidate. This includes a salary range commensurate with industry standards and a comprehensive benefits program.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter outlining your relevant skills and experience. We look forward to hearing from you

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