Validation Engineer: Process & Equipment Validation

Abbott Laboratories; Ireland; Remote; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Job summary

Abbott Diabetes Care Kilkenny is seeking a Validation Engineer to lead qualification activities ensuring compliant, high-quality manufacturing processes at our Kilkenny site. The role collaborates with R&D, QA, PMO and Global Engineering to develop validation strategies for new products and sustain existing ones.

In this regulation-driven environment, you will drive process improvements, generate and approve validation documents, and mentor junior engineers while maintaining adherence to cGMP

Qualifications

• NFQ Level 7 qualification in Engineering, Science, Manufacturing, or related technical field.
• Minimum of 2 years' relevant industry experience in a regulated manufacturing environment.
• Knowledge of validation methodologies, qualification activities, and cGMP requirements.

Responsibilities

• Lead Process Validation and Equipment Qualification activities for sustaining projects.
• Develop and implement validation strategies for new product introductions with R&D, Quality Assurance, PMO and Global Engineering.
• Complete impact assessments for proposed process changes and new products to determine validation requirements.
• Generate, execute, review, and approve validation protocols and validation reports.
• Support Process and Software Validation activities across the manufacturing site.
• Identify opportunities to improve manufacturing processes and software systems.
• Support the implementation and validation of process improvements.
• Drive compliance and operational excellence through effective validation practices.
• Manage multiple projects and priorities while adhering to timelines.
• Communicate project progress and validation status updates to management and stakeholders.
• Collaborate with cross-functional teams to ensure successful project delivery.
• Provide guidance and mentoring to junior engineering team members.
• Ensure compliance with corporate policies, procedures and regulatory requirements.
• Maintain current understanding of cGMP requirements and industry regulations.

Skills

Process Validation

Equipment Qualification

Validation methodologies

cGMP knowledge

Cross-functional collaboration

Mentoring

Education

NFQ Level 7 in Engineering

Tools

Validation protocols

Validation reports

Job description

Abbott Diabetes Care Kilkenny is seeking a Validation Engineer to lead qualification activities ensuring compliant, high-quality manufacturing processes at our Kilkenny site. The role collaborates with R&D, QA, PMO and Global Engineering to develop validation strategies for new products and sustain existing ones.

In this regulation-driven environment, you will drive process improvements, generate and approve validation documents, and mentor junior engineers while maintaining adherence to cGMP