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Highly Skilled Validation Specialist

2 weeks ago


Shannon, Ireland beBeeValidation Full time
Job Summary

We are seeking a highly skilled validation specialist to develop and deliver validation packages for bespoke automated equipment within a fast-paced, high-technology automation company. 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 plans.
  • Develop and review user requirements specifications, functional design specifications, hardware design specifications, and software design specifications.
  • Create, review, and approve commissioning documentation.
  • Develop, review, and approve requirements traceability matrix documentation.
  • Assess and approve failure mode and effects analysis documentation.
  • Develop and review user manuals.
  • Oversee factory acceptance test and site acceptance test 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.
Key Skills & Abilities:
  • 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.
Additional Skills (Preferred):
  • Knowledge of 21 CFR Part 11 requirements, electronic records/electronic signatures, and data integrity guidelines.
  • Knowledge in Allen Bradley PLC software, FactoryTalk View software, and coordinate engineers on testing, including database and SQL server testing.
What We Offer:

In our organisation, we offer a comprehensive benefits package to support employees' well-being and professional development, including flexible work arrangements, health insurance contributions, company bonus, maternity and paternity leave, pension plan, training support, and various wellness initiatives.

About Us:

Our organisation is a trusted automation partner empowering customers to innovate, produce, and scale through technology-enabled manufacturing. Our team operates across advanced manufacturing space in facilities spanning America and Europe. With centralized engineering, technology, and support, we deliver transformative automation solutions that increase quality, production, and efficiency.