Lead Technical Validator

2 weeks ago

Limerick, Limerick, Ireland beBeeValidation Full time €80,000 - €120,000

The Role of Lead Validation Engineer

Job Overview:

This position offers a unique opportunity to expand your technical expertise in a cutting-edge technology environment.

As the validation lead, you will oversee the team in creating a comprehensive validation plan, strategy, and output document. The role requires an understanding of CSV/software integration and experience with capital equipment validation. A strong background in automation process validation is also essential, including knowledge of GxP guidelines, FDA 21 CFR Part 11, ISO Standards, and Validation Lifecycle Management.

Responsibilities:
  • Action plans developed for key deliverables
  • FAT & SAT protocol reports and test plans completed
  • IQ | OQ | PQ documentation reports completed
Key Skills and Qualifications:

This role demands strong Computer System Validation (CSV) processes, including risk-based approaches, qualification testing, validation protocols, and traceability matrix development. Proficiency in validating interfaces between different systems, software testing, and documentation/reporting are also crucial.

Benefits:

As the successful candidate, you will be responsible for developing the overall validation and qualification plan/strategy, creating quality validation process flows, and promoting common approaches to documentation and strategies.

Requirements:

The ideal candidate will have experience working with QA teams and leading/coordinating validation activities.

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