Validation Specialist

4 days ago


Cork, Cork, Ireland i-Pharm Consulting Full time

Company Overview

i-Pharm Consulting is a leading provider of pharmaceutical consulting services.

We are seeking an experienced Senior Validation Engineer to join our team.

This role will play a key part in ensuring compliance within a cGMP-regulated environment, with a focus on Cleaning Validation, including Recovery and Cleanability studies.

The ideal candidate will have a background in pharmaceutical or biopharmaceutical manufacturing and experience in cleaning validation, including recipe development and optimisation, cleanability/recovery studies, and cleaning verification using TOC, ICP, and swab methods.

Job Description

As a Senior Validation Engineer, you will be responsible for developing, reviewing, and executing qualification and validation protocols, including Cycle Development (CD) and Performance Qualification (PQ) for mobile vessels (CIP) and parts washers (COP).

  • Design, author, review, approve, and execute validation documentation and change controls.
  • Identify and resolve technical issues encountered during validation activities.
  • Drive compliance with cGMP, FDA, and ISO regulations, supporting audits and regulatory submissions.
  • Represent the validation team in cross-functional projects and global technical discussions.
Requirements

To be successful in this role, you will need:

  • Experience in cleaning validation, including recipe development and optimisation, 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 analyse complex data, link findings to equipment performance, and identify out-of-specification results.
  • Excellent written and verbal communication skills to effectively collaborate with internal teams and external regulatory bodies.


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