Quality Validation Engineer

     

JOB DESCRIPTION:

Purpose of the Role:

As a Quality Validation Engineer, you will be responsible for creating and maintaining validation documentation for both new and existing systems and processes subject to design controls. You will ensure validation activities are effectively executed for equipment, processes, facilities, and systems used in the manufacture, control, and storage of products, ensuring compliance with Abbott Quality System requirements and regulatory standards.

As part of a growing organization, you will have the opportunity to work on impactful projects, collaborate with global teams, and travel to vendor locations across Europe and the United States for training and development.

Experience supporting site start-ups, facility expansions, or building validation programs from the ground up would be highly advantageous.

Key Responsibilities

• Support the development, implementation, and continuous improvement of the site Validation Program.

• Develop, review, execute, and maintain validation documentation, including protocols, reports, risk assessments, and validation plans.

• Ensure validation activities are performed in compliance with divisional procedures, regulatory requirements, and industry best practices.

• Develop and maintain Quality System procedures, work instructions, and training materials.

• Monitor and maintain the compliance status of validation and quality records.

• Review and approve validation documentation in accordance with company policies and procedures.

• Collaborate with Quality, Engineering, Manufacturing, and Operations teams to support validation and compliance objectives.

• Support internal, customer, and regulatory audits as required.

• Track and communicate validation metrics, compliance trends, risks, and continuous improvement initiatives.

• Contribute to maintaining a high-performing quality culture that ensures the delivery of safe and effective products.

• Support activities related to Design Controls and Design Transfer where required.

Education & Experience:

• Bachelor's Degree in Engineering, Science, Manufacturing, Quality, or a related discipline.

• Minimum 4 years' experience within an Engineering, Manufacturing, Scientific, or Quality environment.

• 5+ years' experience in validation, including process, equipment, facilities, utility, and/or software validation.

• Experience working within a regulated industry such as Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare.

• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and associated quality system requirements.

• Experience authoring and reviewing validation lifecycle documentation.

• Understanding of risk management principles and validation best practices.

Preferred

• Experience supporting site start-ups, new product introductions, technology transfers, or greenfield projects.

• Understanding of Design Controls and Design Transfer processes.

• Strong problem-solving, communication, and stakeholder management skills.

• Ability to work independently while effectively collaborating across multiple functions.

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

• Family health insurance,

• Excellent pension scheme

• Life assurance

• Career Development

• Fantastic new facility

• Growing business plus access to many more benefits.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable