Validation Expert

1 week ago

Shannon, Ireland beBeeSpecialist Full time €80,000 - €100,000
Job Title:
Validation Specialist

Job Summary:
We are seeking a skilled Validation Specialist 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.

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.

Benefits:

In our company, 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.

About Us:

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

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