Chief Automation Specialist

1 day ago

Shannon, Ireland beBeeAutomation Full time €80,000 - €110,000
Validation Engineer Position

We are seeking a skilled Validation Engineer to develop and deliver validation packages for automated equipment within a fast-paced, high-technology automation company. This role focuses on supporting manufacturing customers by ensuring compliance with validation standards throughout all project stages.

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.
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.
What We Offer:

In AIR, we offer a comprehensive benefits package to support our 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.

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