Validation Engineer

apartmentMorgan McKinley placeDublin calendar_month 

We are seeking a Validation Engineer to join our client's team within the biopharmaceutical sector. In this role, you will play a pivotal part in ensuring that equipment, processes, and systems are fully compliant with regulatory standards. You will work collaboratively with cross-functional teams to validate both new and existing manufacturing platforms, resolve quality issues, and uphold the highest standards of documentation and compliance.

Key Responsibilities
  • Lead validation projects for new and modified manufacturing equipment, processes, and utilities (IQ, OQ, PQ protocols).
  • Write and review validation documentation: validation plans, protocols, reports, risk assessments, and change controls.
  • Collaborate with Quality Assurance, Engineering, and Manufacturing to resolve deviation investigations and CAPAs.
  • Perform validation and commissioning activities, including qualification testing and acceptance.
  • Support continuous improvement initiatives, focusing on process optimisation and compliance.
  • Ensure validation activities meet internal SOPs and external regulatory requirements.
Qualifications
  • Degree in a science, engineering or related discipline is essential
  • 3+ years in validation engineering within a GMP-regulated biopharmaceutical or pharmaceutical environment.
  • Demonstrated experience with IQ, OQ, PQ lifecycle for equipment and processes.
  • Proficient in producing validation documentation and technical reports.
  • Excellent interpersonal, communication, and project management skills.
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