Cleanroom Validation Specialist

2 days ago


The Municipal District of Carlow, Ireland ENG Bauen Full time
About the Role

We are seeking a Senior Validation Engineer to join our team at ENG Bauen, a global talent management and advisory consultancy specializing in the Pharmaceutical and Energy sectors.

The successful candidate will have hands-on project experience and a strong background in project delivery, from concept to commissioning, qualification, and validation. You will work closely with cross-functional teams to ensure compliance with relevant regulations while supporting key validation activities.

Key Responsibilities:

  • Partner with local project teams to deliver Automation and IT aspects of capital projects.
  • Work with site teams developing and executing validation plans, protocols (IQ, OQ, PQ), and reports.
  • Maintain and review validation documentation, ensuring compliance with cGMP, FDA, EMA, and other relevant standards.
  • Collaborate with engineering, quality, and operations teams to implement validation strategies.
  • Perform residue analysis and interpret results to verify cleaning effectiveness.
  • Conduct risk assessments and gap analyses to optimize validation activities.
  • Provide technical competence in commissioning and qualification (C&Q) activities.

Requirements for the Role:

  • Bachelor's degree in Engineering, Computer Science, or other technical degree.
  • Experience in cleaning validation within a pharmaceutical, biotech, or medical device environment.
  • Proficiency in validation software and laboratory analytical techniques.
  • Excellent written and oral communication skills, as well as strong presentation skills.


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