Validation Specialist

6 days ago


The Municipal District of Carlow, Ireland RT Full time

**Job Overview:**

We are currently recruiting for a highly skilled Validation Specialist to join our team at RT Lane Recruitment.

The successful candidate will be responsible for leading the validation of pharmaceutical equipment and ensuring compliance with regulatory guidelines.

About the Role:

  1. Conducting equipment performance qualifications, including cleaning and sterilization validation.
  2. Authoring project validation master plans, SOPs, and documentation updates.
  3. Executing validation studies, analyzing validation data, and resolving technical issues.
  4. Working in a cross-functional team and independently to accomplish validation project objectives.
  5. Leading an experienced Senior/Lead Engineering (CQV/Technical Engineer) with broad experience in Vial and Syringe Filling operations.

Key Responsibilities:

  • Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
  • Cleaning Validation in Biotech facility & Cleaning Processes.
  • Sterilisation – Autoclave & Load Qualification.
  • Single Use Technologies – SUT and SU components/manifolds.
  • Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation.
  • Ancillary Equipment for Bio-processing – Tube Welders/Sealers/Filter Integrity/Glove Integrity Testing.
  • Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
  • Parenteral Product Visual Inspection (Automated Inspection).
  • High Potency and ICH Q5 products & containment methodologies.

Requirements:

  • Minimum 6 years C&Q/QA/QC/Validation experience in highly regulated industry.
  • Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project or new facility introduction.
  • Presenting of QA/QC/Validation documents to regulatory agencies/inspectors and defending approach.
  • SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components/Vaporised Hydrogen Peroxide Isolators/Clean Utilities & Transfer Panels/Vial & Syringe Filling & Inspection.
  • Working knowledge of ASTM E2500/Eudralex/FDA/ISPE guidelines.
  • Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.

Qualifications & Education:

  • Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences, Computer Sciences or applied Technical/Engineering qualification.
  • A proven track record in delivering excellence.


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