Validation Specialist

Job description

Role: Validation Specialist

Reporting to: Engineering and Facilities Manager

Location: Dublin 15

Employment Type: Full Time

Industry: Logistics and Supply Chain

About Us:

Noel Group are partnered with a unique supply chain management company with a strong service portfolio within the areas of Transportation, Refrigeration, Storage and Value-Added Services. They are renowned for delivering innovative and customised services to our clients and our commitment to excellence and customer-centric approach have established us as a trusted partner in the industry.

About the Role:

We are recruiting for an experienced and motivated Validation Specialist to join our team. This is a fantastic opportunity for professionals with a background in validation to further their career. This role will work cross functionally and be instrumental in forging the company’s validation processes.

Key role responsibilities:

* Generation, execution and close out of validation projects relating to existing products

and new product introductions.

* Participate in project teams and assist in determining project schedules and the

appropriate levels of validation.

* Execution and documenting risk assessments with respect to validation activities.

* Investigate, track and resolve deviations during qualification activities.

* Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.

* Adopts positive cross functional relations.

* Assess validation requirements (new equipment, change controls, etc.), monitor project

status, and ensure timely updates.

* Maintain validation status through monthly reports and meetings, collaborating with

project managers to adhere to schedules.

* Ensure GMP compliance, stay updated on validation innovations.

* Generate and execute validation protocols, review project change controls, and prepare

necessary documentation and reports.

* Contribute to developing company validation standards and assist with department

growth as needed.

* Present professionally to management and auditors, support processes, and address

queries during regulatory inspections.

* Liaise with relevant Q.A. personnel to complete project documentation within defined

time frames

About You:

* Bachelor’s degree in Science, Engineering, Technology or a related discipline.

* 3 years of hands-on experience working as a validation engineer/specialist in a GMP

environment,

* Experience within a similar role – with focus on validation projects

* Knowledge of HVAC/Refrigeration systems including automation.

* Excellent communication skills including ability to present technical information to non SME audience.

* Committed to deliver outstanding customer service.

* A self-starter who can drive long-term objectives.

* Ability to gather, understand, analyse and interpret information and concepts quickly.

* Experience in end-to-end qualification. Developing URS, IQ/OQ/PQ.

* A third level qualification in a relevant field

* A team player, proactive in approach and solution focussed