83 Validation Engineer jobs in Ireland
Validation Engineer
Kilkenny, Leinster
Abbott
Posted today
Job Viewed
Job Description
**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Diabetes Care Kilkenny**
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
**This is how you can make a difference at Abbott:**
In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.
**You will be responsible for:**
+ Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
+ Complete impact assessments of proposed changes and/or new products and determine scope of validation work
+ Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
+ Identification of improvements to manufacturing process & software and assist with implementation of same
+ Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management
+ Provide direction and mentoring to junior engineers as required
+ Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
+ Knowledge of cGMP and industry regulations
**QUALIFICATIONS AND EXPERIENCE**
+ Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
+ Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
+ 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
+ Basic understanding of design controls, design transfer and validation lifecycle.
+ Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Diabetes Care Kilkenny**
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
**This is how you can make a difference at Abbott:**
In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.
**You will be responsible for:**
+ Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
+ Complete impact assessments of proposed changes and/or new products and determine scope of validation work
+ Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
+ Identification of improvements to manufacturing process & software and assist with implementation of same
+ Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management
+ Provide direction and mentoring to junior engineers as required
+ Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
+ Knowledge of cGMP and industry regulations
**QUALIFICATIONS AND EXPERIENCE**
+ Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
+ Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
+ 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
+ Basic understanding of design controls, design transfer and validation lifecycle.
+ Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
0
Validation Engineer
Cork, Munster
PM Group
Posted today
Job Viewed
Job Description
Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are looking for an experienced Validation Engineer to work on a Client site in Cork. The Validation Engineer will be responsible for the equipment Validation of a technology transfer of existing processes from another site. Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization). Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply. Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements. Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria. Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards. Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test. Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution. Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems. Qualifications B.S. in Engineering and 3-7 years of experience or related equivalent work experience Must have experience with cGMPs and Good Engineering Practices. Experience in executing multiple projects and participating on cross-functional project teams Knowledge of automation validation preferred Knowledge of Quality control equipment qualification a plus
This advertiser has chosen not to accept applicants from your region.
1
Validation Engineer
Longford, Leinster
Russell Brennan Keane
Posted today
Job Viewed
Job Description
Our client, a privately owned Irish company based in Longford, is seeking to recruit a Validation Engineer. This person will be responsible for supporting all validation activities associated with the successful qualification of new tools/ product introduction. He or She will report to the Validation Engineer Manager and will support the organization to achieve the New product introduction objectives. Key Responsibilities: Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge. Developing and implementing solutions to sustain and improve the QMS. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards. Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented. Generation of risk assessments, covering cleaning, validation, and process. Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols. Directly supports GMP and regulatory audits. Prepare and deliver training modules as required. Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis Support continuous improvement through Lean Six Sigma methodologies. Execution / development of change controls. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 whys etc.; Implement subsequent corrective action through the change management system. Participate / lead cross functional teams including liaising with vendors on projects. Qualifications & Key Attributes Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience. Experience in statistical analysis (Minitab) / SPC / validations. Excellent interpersonal, communication, influencing, and facilitation skills A minimum of 2 years experience as a Validation Engineer within an Injection moulding or medical manufacturing environment. Requirements Minimum of 5 years experience working with Medical Devices Strong expertise and knowledge of Injection Moulding Proven track record in validation within regulated environments Skills: "Polymer" "Engineering" "Injection moulding" "Lean six methods" "minitab"
This advertiser has chosen not to accept applicants from your region.
2
Validation Engineer
Cavan, Ulster
Collins McNicholas
Posted today
Job Viewed
Job Description
Our client, a leading global healthcare company based in Cavan, is recruiting for a Validation Engineer. The Role As a Validation Engineer you will work within the Packing Department Projects division supporting a team of Project Engineers in the delivery of improvements to help integrate new products or processes into the existing manufacturing area, through the creation of documents and execution of validation work in compliance with current regulatory and company requirements. The successful candidate will report directly to the Packing Principal Programme Manager. Major Responsibilities Provide direction, documentation, execution and review for project validation activities. Develop project validation documentation during the FEP process and throughout the lifecycle of projects. Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects Education Required Bachelors Degree in Engineering or equivalent discipline. Minimum of 3 years relevant experience in Engineering. Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage). Good mental ability to logically follow a line of though for problem solving. For a confidential discussion and more information on the role, please contact Colin Byrne. Skills: validation engineer pharmaceutical
This advertiser has chosen not to accept applicants from your region.
3
Validation Engineer
Longford, Leinster
Collins McNicholas
Posted today
Job Viewed
Job Description
Validation Engineer Permanent or SubContractor Opportunity We are seeking a talented Validation Engineer to join our team, where youll have the opportunity to support cutting-edge projects and make a real impact on product quality and compliance for our client based in the Midlands. This position is available on either a permanent basis or through a subcontract arrangement, offering flexibility for the right candidate. Responsibilities: As a Validation Engineer, you will: Write and execute process validation protocols and reports for new product introductions and revalidations. Support continuous improvement through Lean Six Sigma methodologies. Drive compliance with ISO 13485 and ISO 14001 standards. Lead and participate in cross-functional teams, including vendor liaison on key projects. Conduct risk assessments and root cause analyses, implementing corrective actions via change management. Review and execute FAT and SAT protocols. Directly support GMP and regulatory audits. Deliver training and mentor colleagues to strengthen validation knowledge across the business. Perform data analysis to guide informed decision-making and improvements. Requirements: Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience. Minimum 2 years experience as a Validation Engineer in injection moulding or medical device manufacturing. Strong background in statistical analysis (Minitab), SPC, and validation methodologies. Excellent communication, interpersonal, and influencing skills. Hands-on experience in problem solving (FMEA, Fishbone diagrams, 5 Whys, etc.). Why Join? Be part of an innovative, dynamic team driving new product introduction and process excellence. Work in a regulated, high-quality environment with opportunities to expand your expertise. Flexible engagement options: join on a permanent basis or as a subcontractor to suit your career path. For more details on the position reach out to Gillian Nicholson Skills: validation validation engineer polymer
This advertiser has chosen not to accept applicants from your region.
4
Validation engineer
Cavan, Ulster
Collins McNicholas
Posted today
Job Viewed
Job Description
Our client, a leading global healthcare company based in Cavan, is recruiting for a Validation Engineer.
The Role As a Validation Engineer you will work within the Packing Department Projects division supporting a team of Project Engineers in the delivery of improvements to help integrate new products or processes into the existing manufacturing area, through the creation of documents and execution of validation work in compliance with current regulatory and company requirements.
The successful candidate will report directly to the Packing Principal Programme Manager.
Major Responsibilities Provide direction, documentation, execution and review for project validation activities.
Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects Education Required Bachelors Degree in Engineering or equivalent discipline.
Minimum of 3 years relevant experience in Engineering.
Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage).
Good mental ability to logically follow a line of though for problem solving.
For a confidential discussion and more information on the role, please contact Colin Byrne.
Skills: validation engineer pharmaceutical
The Role As a Validation Engineer you will work within the Packing Department Projects division supporting a team of Project Engineers in the delivery of improvements to help integrate new products or processes into the existing manufacturing area, through the creation of documents and execution of validation work in compliance with current regulatory and company requirements.
The successful candidate will report directly to the Packing Principal Programme Manager.
Major Responsibilities Provide direction, documentation, execution and review for project validation activities.
Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects Education Required Bachelors Degree in Engineering or equivalent discipline.
Minimum of 3 years relevant experience in Engineering.
Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage).
Good mental ability to logically follow a line of though for problem solving.
For a confidential discussion and more information on the role, please contact Colin Byrne.
Skills: validation engineer pharmaceutical
This advertiser has chosen not to accept applicants from your region.
5
Validation engineer
Longford, Leinster
Russell Brennan Keane
Posted today
Job Viewed
Job Description
Our client, a privately owned Irish company based in Longford, is seeking to recruit a Validation Engineer.
This person will be responsible for supporting all validation activities associated with the successful qualification of new tools/ product introduction.
He or She will report to the Validation Engineer Manager and will support the organization to achieve the New product introduction objectives.
Key Responsibilities: Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
Developing and implementing solutions to sustain and improve the QMS.
Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Generation of risk assessments, covering cleaning, validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Directly supports GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis Support continuous improvement through Lean Six Sigma methodologies.
Execution / development of change controls.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 whys etc.; Implement subsequent corrective action through the change management system.
Participate / lead cross functional teams including liaising with vendors on projects.
Qualifications & Key Attributes Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
Experience in statistical analysis (Minitab) / SPC / validations.
Excellent interpersonal, communication, influencing, and facilitation skills A minimum of 2 years experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Requirements Minimum of 5 years experience working with Medical Devices Strong expertise and knowledge of Injection Moulding Proven track record in validation within regulated environments Skills: "Polymer" "Engineering" "Injection moulding" "Lean six methods" "minitab"
This person will be responsible for supporting all validation activities associated with the successful qualification of new tools/ product introduction.
He or She will report to the Validation Engineer Manager and will support the organization to achieve the New product introduction objectives.
Key Responsibilities: Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
Developing and implementing solutions to sustain and improve the QMS.
Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Generation of risk assessments, covering cleaning, validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Directly supports GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis Support continuous improvement through Lean Six Sigma methodologies.
Execution / development of change controls.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 whys etc.; Implement subsequent corrective action through the change management system.
Participate / lead cross functional teams including liaising with vendors on projects.
Qualifications & Key Attributes Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
Experience in statistical analysis (Minitab) / SPC / validations.
Excellent interpersonal, communication, influencing, and facilitation skills A minimum of 2 years experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Requirements Minimum of 5 years experience working with Medical Devices Strong expertise and knowledge of Injection Moulding Proven track record in validation within regulated environments Skills: "Polymer" "Engineering" "Injection moulding" "Lean six methods" "minitab"
This advertiser has chosen not to accept applicants from your region.
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6
Validation engineer
Cork, Munster
PM Group
Posted today
Job Viewed
Job Description
Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs.
Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are looking for an experienced Validation Engineer to work on a Client site in Cork.
The Validation Engineer will be responsible for the equipment Validation of a technology transfer of existing processes from another site.
Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization).
Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply.
Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards.
Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ.
Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution.
Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems.
Qualifications B.
S.
in Engineering and 3-7 years of experience or related equivalent work experience Must have experience with c GMPs and Good Engineering Practices.
Experience in executing multiple projects and participating on cross-functional project teams Knowledge of automation validation preferred Knowledge of Quality control equipment qualification a plus
Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are looking for an experienced Validation Engineer to work on a Client site in Cork.
The Validation Engineer will be responsible for the equipment Validation of a technology transfer of existing processes from another site.
Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization).
Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply.
Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards.
Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ.
Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution.
Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems.
Qualifications B.
S.
in Engineering and 3-7 years of experience or related equivalent work experience Must have experience with c GMPs and Good Engineering Practices.
Experience in executing multiple projects and participating on cross-functional project teams Knowledge of automation validation preferred Knowledge of Quality control equipment qualification a plus
This advertiser has chosen not to accept applicants from your region.
7
Validation engineer
Longford, Leinster
Collins McNicholas
Posted today
Job Viewed
Job Description
Validation Engineer Permanent or Sub Contractor Opportunity We are seeking a talented Validation Engineer to join our team, where youll have the opportunity to support cutting-edge projects and make a real impact on product quality and compliance for our client based in the Midlands.
This position is available on either a permanent basis or through a subcontract arrangement, offering flexibility for the right candidate.
Responsibilities: As a Validation Engineer, you will: Write and execute process validation protocols and reports for new product introductions and revalidations.
Support continuous improvement through Lean Six Sigma methodologies.
Drive compliance with ISO 13485 and ISO 14001 standards.
Lead and participate in cross-functional teams, including vendor liaison on key projects.
Conduct risk assessments and root cause analyses, implementing corrective actions via change management.
Review and execute FAT and SAT protocols.
Directly support GMP and regulatory audits.
Deliver training and mentor colleagues to strengthen validation knowledge across the business.
Perform data analysis to guide informed decision-making and improvements.
Requirements: Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
Minimum 2 years experience as a Validation Engineer in injection moulding or medical device manufacturing.
Strong background in statistical analysis (Minitab), SPC, and validation methodologies.
Excellent communication, interpersonal, and influencing skills.
Hands-on experience in problem solving (FMEA, Fishbone diagrams, 5 Whys, etc.).
Why Join? Be part of an innovative, dynamic team driving new product introduction and process excellence.
Work in a regulated, high-quality environment with opportunities to expand your expertise.
Flexible engagement options: join on a permanent basis or as a subcontractor to suit your career path.
For more details on the position reach out to Gillian Nicholson Skills: validation validation engineer polymer
This position is available on either a permanent basis or through a subcontract arrangement, offering flexibility for the right candidate.
Responsibilities: As a Validation Engineer, you will: Write and execute process validation protocols and reports for new product introductions and revalidations.
Support continuous improvement through Lean Six Sigma methodologies.
Drive compliance with ISO 13485 and ISO 14001 standards.
Lead and participate in cross-functional teams, including vendor liaison on key projects.
Conduct risk assessments and root cause analyses, implementing corrective actions via change management.
Review and execute FAT and SAT protocols.
Directly support GMP and regulatory audits.
Deliver training and mentor colleagues to strengthen validation knowledge across the business.
Perform data analysis to guide informed decision-making and improvements.
Requirements: Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
Minimum 2 years experience as a Validation Engineer in injection moulding or medical device manufacturing.
Strong background in statistical analysis (Minitab), SPC, and validation methodologies.
Excellent communication, interpersonal, and influencing skills.
Hands-on experience in problem solving (FMEA, Fishbone diagrams, 5 Whys, etc.).
Why Join? Be part of an innovative, dynamic team driving new product introduction and process excellence.
Work in a regulated, high-quality environment with opportunities to expand your expertise.
Flexible engagement options: join on a permanent basis or as a subcontractor to suit your career path.
For more details on the position reach out to Gillian Nicholson Skills: validation validation engineer polymer
This advertiser has chosen not to accept applicants from your region.
8
QA Validation Engineer
Sligo, Connacht
AbbVie
Posted today
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo. In this role, you will join AbbVie's Quality team, supporting the development and maintenance of the site validation program and ensuring compliance with AbbVie, FDA, and cGMP standards. You join a team of experienced validation experts who ensure that our processes and equipment perform to meet the highest standards of product safety, quality, and regulatory compliance across existing products and new products that are being introduced to our site.
Responsibilities:
+ Coordinate, implement, and participate in equipment, process, and software validation activities to maintain regulatory compliance.
+ Develop, execute, and maintain validation master plans, project schedules, protocols, reports, and investigations.
+ Review, approve, and manage quality documents, change control, exception events, and corrective actions.
+ Train team members, support continuous improvement, and ensure cGMP compliance across production areas.
+ Communicate validation activities to peers and management; elevate issues as needed.
Qualifications
+ Bachelor's degree in engineering or a scientific discipline required.
+ Minimum 3 years' validation/QA experience in medical device manufacturing (plastics, moulding, assembly).
+ Solid understanding of cGMP and regulatory requirements.
+ Strong communication, interpersonal, troubleshooting, and organisational skills.
+ Ability to work independently and as part of a team, prioritise tasks, and multitask effectively.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo. In this role, you will join AbbVie's Quality team, supporting the development and maintenance of the site validation program and ensuring compliance with AbbVie, FDA, and cGMP standards. You join a team of experienced validation experts who ensure that our processes and equipment perform to meet the highest standards of product safety, quality, and regulatory compliance across existing products and new products that are being introduced to our site.
Responsibilities:
+ Coordinate, implement, and participate in equipment, process, and software validation activities to maintain regulatory compliance.
+ Develop, execute, and maintain validation master plans, project schedules, protocols, reports, and investigations.
+ Review, approve, and manage quality documents, change control, exception events, and corrective actions.
+ Train team members, support continuous improvement, and ensure cGMP compliance across production areas.
+ Communicate validation activities to peers and management; elevate issues as needed.
Qualifications
+ Bachelor's degree in engineering or a scientific discipline required.
+ Minimum 3 years' validation/QA experience in medical device manufacturing (plastics, moulding, assembly).
+ Solid understanding of cGMP and regulatory requirements.
+ Strong communication, interpersonal, troubleshooting, and organisational skills.
+ Ability to work independently and as part of a team, prioritise tasks, and multitask effectively.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
9