Automation Validation Expert

1 week ago

Shannon, Ireland beBeeValidation Full time €60,000 - €80,000
Job Description

We are seeking a 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 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.

This position requires in-depth knowledge of GAMP requirements and a strong understanding of the software system development lifecycle for automated equipment. Additionally, it is a customer-facing role responsible for meeting customer requirements and fostering key customer relationships.

Key Responsibilities:
  1. Develop, review, and approve Validation Project Plans.
  2. Develop and review User Requirements Specifications, Functional Design Specifications, Hardware Design Specifications, and Software Design Specifications.
  3. Create, review, and approve commissioning documentation.
  4. Develop, review, and approve Requirements Traceability Matrix documentation.
  5. Assess and approve Failure Mode and Effects Analysis documentation.
  6. Develop and review User Manuals.
  7. Oversee Factory Acceptance Test and Site Acceptance Test documentation.
  8. Collect qualification test data and provide technical input to resolve discrepancies and deviations.
Required Skills & Qualifications

To succeed in this role, you should possess:

  • A bachelor's degree in science, engineering, or a related discipline.
  • Minimum of 3 years' experience in a validation role within a regulated environment.
Benefits

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.
  • Various wellness initiatives.
About Us

As a trusted automation partner, we empower our customers to innovate, produce, and scale through technology-enabled manufacturing.

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