Automated Equipment Validation Professional

2 weeks ago

Shannon, Ireland beBeeValidation Full time €70,000 - €110,000

Job Overview:

We are seeking a skilled Validation Specialist to develop and deliver validation packages for bespoke automated equipment in a fast-paced, high-technology automation company.

This role focuses on supporting 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 optimizing cost efficiency.

Key Responsibilities:

  • Develop, review, and approve validation project 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.

Required Skills & Qualifications:

  • Proven experience in developing validation documentation for the pharmaceutical and medical device industries.
  • Strong organizational 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.

About Our Company:

  • Established in 2023, our company is a trusted automation partner empowering customers to innovate, produce, and scale through technology-enabled manufacturing.
  • Our five-hundred-person world-class team operates across 350,000 sq ft of advanced manufacturing space in four facilities spanning America and Europe.
  • With centralized engineering, technology, and support, we deliver transformative automation solutions that increase quality, production, and efficiency.

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