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Pharmaceutical Validation Professional with Cleaning Validation Experience

1 week ago

Cork, Cork, Ireland i-Pharm Consulting Full time

i-Pharm Consulting's Vision

Validation Expert with cGMP Compliance Focus

We are committed to driving manufacturing excellence and R&D across our global network. Our vision is to make a difference in the lives of patients and communities worldwide.

We are seeking a highly skilled Senior Validation Engineer to join our team and contribute their expertise in a high-impact role. As a key member of our validation team, you will focus on cleaning validation, including recovery and cleanability studies.

Key Responsibilities:

  • Develop, review, and execute qualification and validation protocols, including cycle development and performance qualification for mobile vessels and parts washers.
  • Design, author, review, approve, and execute validation documentation and change controls.
  • Identify and resolve technical issues encountered during validation activities.
  • Conduct risk assessments, root cause analysis, and deviation investigations.
  • Collaborate with production, maintenance, and quality teams to ensure validation requirements are met.
  • Drive compliance with cGMP, FDA, and ISO regulations, supporting audits and regulatory submissions.
  • Support continuous improvement initiatives through lean six sigma methodologies.
  • Represent the validation team in cross-functional projects and global technical discussions.

Requirements:

  • Experience in cleaning validation, including recipe development and optimization, cleanability/recovery studies, and cleaning verification using TOC, ICP, and swab methods.
  • Strong knowledge of validation within a pharmaceutical manufacturing environment.
  • Hands-on experience with deviation management, change control, and process monitoring systems.
  • Relevant technical qualification in applied pharmaceutical, biological, or chemical sciences, or engineering.
  • Ability to analyze complex data, link findings to equipment performance, and identify out-of-specification results.
  • Strong problem-solving and analytical skills with a hands-on approach.
  • Excellent written and verbal communication skills to effectively collaborate with internal teams and external regulatory bodies.