Validation Expert

3 days ago


The Municipal District of Carlow, Ireland PE Global Full time

PE Global is seeking a seasoned expert to join our team as a Validation Engineer in a GMP manufacturing environment.

About the Role

The successful candidate will be responsible for supporting Cleaning Validation, including Recovery/Cleanability studies, and will work closely with production, maintenance, and quality teams to ensure seamless execution of Cycle Development & Performance Qualification activities.

Key Responsibilities:
  • Design, author, review, approve, and execute qualification/validation documentation and cycle development studies according to standard approval processes.
  • Develop and implement change controls to ensure compliance with global policies, procedures, and guidelines.
  • Analyze technical issues during study execution and resolve them efficiently.
  • Collaborate with production, maintenance, and quality representatives to ensure seamless execution of Cycle Development & Performance Qualification activities.
Requirements:
  • Proven experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), with expertise in recipe development & optimisation, cleaning verification, cleanability, and recovery studies.
  • Considerable experience in a comparable role, with the ability to operate 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.
  • Demonstrable experience of leading technical-related projects, with knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System).
  • Excellent communication, presentation, and interpersonal skills to interface effectively with colleagues and external customers.

This is an excellent opportunity for a dedicated and detail-oriented individual to join our team and contribute to the success of our pharmaceutical client.



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