About Us:
Founded in 1968 McArdle Skeath offer a unique supply chain management service portfolio within the areas of Transportation, Refrigeration, Storage and Value-Added Services. We 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
Job Types: Full-time, Permanent
Pay: €37,000.00-€47,000.00 per year
Benefits:
* Bike to work scheme
* Company events
* On-site parking
Language:
* English (required)
Work authorisation:
* Ireland (required)
Work Location: In person