Lead Validation Expert

2 weeks ago

Shannon, Ireland beBeeValidation Full time €80,000 - €100,000
Job Summary

We are seeking a highly skilled Validation Specialist to develop and deliver validation solutions for bespoke automated equipment within a fast-paced, high-technology industry.

This role focuses on supporting FDA-regulated manufacturing customers by ensuring compliance with validation standards throughout all project stages, from proposal to final delivery. The Validation Specialist will define validation strategies, plan project documentation, and execute validation activities in alignment with project objectives while optimising cost efficiency.

Key Responsibilities
  • Develop, review, and approve Validation Project Plans (VPP).
  • Develop and review User Requirements Specifications (URS), Functional Design Specifications (FDS), Hardware Design Specifications (HDS), and Software Design Specifications (SDS).
  • Create, review, and approve commissioning documentation.
  • Develop, review, and approve Requirements Traceability Matrix (RTM) documentation.
  • Assess and approve Failure Mode and Effects Analysis (FMEA) documentation.
  • Develop and review User Manuals.
  • Oversee Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documentation.
  • Collect qualification test data and provide technical input to resolve discrepancies and deviations.
Qualifications & Experience
  • Bachelor's degree in Science, Engineering, or a related discipline.
  • Minimum of 3 years' experience in a validation role within a regulated environment.
Required Skills & Qualifications
  • Proven experience in developing validation documentation for the pharmaceutical and medical device industries.
  • Strong organisational skills with a proactive and solutions-focused mindset.
  • Ability to multitask and manage multiple projects effectively.
  • Excellent communication and stakeholder management skills.
  • Strong technical proficiency, including Microsoft Word, Excel, PowerPoint, and MS Project.
  • Detail-oriented with strong documentation and analytical skills.
  • Ability to work collaboratively across departments.
  • Structured and methodical approach to tasks.
  • Strong time management and problem-solving abilities.
  • Customer-focused approach.
Addtional Skills (Preferred)
  • Knowledge of 21 CFR Part 11 requirements, Electronic Records/Electronic Signatures (ER/ES), and data integrity guidelines.
  • Knowledge in Allen Bradley PLC software, FactoryTalk View software, and coordinate engineers on testing, including database and SQL server testing.

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