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.

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.