112 Qa Validation Engineer jobs in Ireland

Orange Recruitment are sourcing Quality professional looking to make a meaningful impact within a forward thinking and regulated manufacturing environment.

We're seeking a proactive and detail-focused Quality Validation Engineer to join our clients growing team in supporting compliance, process validation, and continuous improvement in alignment with global quality standards.

Responsibilities Ensure the implementation, upkeep, and continual improvement of the company's Quality Management System in compliance with relevant ISO and MDR standards.

Lead and support validation activities (IQ/OQ/PQ) for new and existing processes, including protocol development, execution oversight, and data evaluation.

Coordinate and perform internal quality audits, helping to drive best practices and ensure audit readiness at all times.

Act as a critical support member during customer and regulatory audits, providing documentation and expert input as needed.

Collaborate with cross-functional teams in product development, including process trials and first production runs.

Investigate and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies.

Monitor supplier performance and initiate NCMRs and corrective actions as needed, preventing defects from reaching final product stage.

Compile, analyse, and report quality metrics to leadership and stakeholders, contributing to the continuous improvement strategy.

Assist in the creation and revision of Standard Operating Procedures (SOPs), work instructions, and quality documentation.

Requirements Degree-qualified in Engineering, Science, or a related technical discipline.

Minimum of 3 years' experience in a quality-focused role within a regulated manufacturing environment, ideally medical devices or life sciences.

Certified Internal Auditor (ISO 13485) with hands-on experience leading or participating in audits.

Solid working knowledge of equipment validation, risk-based approaches, and statistical analysis.

Strong understanding of non-conformance handling, CAPA processes, and change control.

Meticulous attention to detail with excellent problem-solving and documentation skills.

Ability to communicate clearly across functions and work effectively both independently and as part of a team.

Position Overview: The Manufacturing Validation Engineer will play a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes in compliance with industry regulations and company standards in the medical device sector.

This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion.

The role requires a blend of engineering, regulatory knowledge, and leadership skills to drive successful project delivery, including documentation, risk management, and effective collaboration across cross-functional teams.

Key Responsibilities: Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.).

Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.

Ensure compliance with current Good Manufacturing Practices (c GMP) and other relevant standards throughout validation processes.

Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.

Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA).

Develop and review validation protocols, reports, and SOPs (Standard Operating Procedures) to ensure all activities are properly documented and compliant with regulatory requirements.

Ensure the traceability and audit readiness of all validation activities, supporting internal audits and regulatory inspections.

Support the creation and review of regulatory filings and submissions as required.

Ensure proper documentation practices, maintaining the highest standards for data integrity and quality assurance throughout the validation process.

Actively participate in continuous improvement efforts within the manufacturing area to optimize equipment performance, reduce waste, and enhance operational efficiency.

Provide training and mentorship to junior engineers or technicians, guiding them through validation protocols, equipment troubleshooting, and best practices.

Contribute to lessons learned meetings and share insights to improve future validation processes.

Lead and manage validation projects from conception through to completion, ensuring all aspects of the project adhere to defined timelines, budgets, and quality standards.

Develop project timelines and schedules, ensuring all milestones are met and delivering the required project updates to senior management and stakeholders.

Coordinate cross-functional teams, including Engineering, Quality Assurance, Manufacturing, Regulatory Affairs, and Suppliers, to ensure the success of validation projects.

Conduct risk assessments for validation activities and ensure mitigation plans are in place.

Track and report on the progress of validation projects and proactively address any potential delays or risks to project timelines.

Prepare and maintain validation documentation and ensure compliance with company standards, including change control documentation, project status reports, and validation summaries.

Skills: Bachelors or Masters degree in Engineering, Mechanical Engineering, Industrial Engineering,or a related field.

5+ years of experience in manufacturing equipment validation, qualification, or a related engineering role within the medical device or pharmaceutical industry.

At least 2 years of experience in project management, leading cross-functional teams and driving complex projects to completion in a regulated environment.

Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and c GMP.

Expertise in validation practices (IQ/OQ/PQ) and associated documentation.

Hands-on experience with manufacturing systems and equipment used in medical device production.

Strong project management skills including the ability to create project timelines, track progress, and mitigate risks.

PMP certification is a plus.

Strong analytical and problem-solving skills, including root cause analysis and CAPA management.

Ability to work collaboratively in a cross-functional team environment.

Excellent communication skills, both written and verbal, with the ability to prepare detailed reports and present findings to management.

Knowledge of industry-specific software, such as LIMS (Laboratory Information Management Systems), ERP (Enterprise Resource Planning), or Veeva Vault, is a plus.

Familiarity with risk management principles (e.g., FMEA, Risk Assessment) and their application in equipment validation.

Skills: validation manufacturing IQOQPQ Equipment qualification risk assessment verification manufacturing engineer

Orange Recruitment are sourcing Quality professional looking to make a meaningful impact within a forward thinking and regulated manufacturing environment.

We're seeking a proactive and detail-focused Quality Validation Engineer to join our clients growing team in supporting compliance, process validation, and continuous improvement in alignment with global quality standards.

Responsibilities Ensure the implementation, upkeep, and continual improvement of the company's Quality Management System in compliance with relevant ISO and MDR standards.

Lead and support validation activities (IQ/OQ/PQ) for new and existing processes, including protocol development, execution oversight, and data evaluation.

Coordinate and perform internal quality audits, helping to drive best practices and ensure audit readiness at all times.

Act as a critical support member during customer and regulatory audits, providing documentation and expert input as needed.

Collaborate with cross-functional teams in product development, including process trials and first production runs.

Investigate and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies.

Monitor supplier performance and initiate NCMRs and corrective actions as needed, preventing defects from reaching final product stage.

Compile, analyse, and report quality metrics to leadership and stakeholders, contributing to the continuous improvement strategy.

Assist in the creation and revision of Standard Operating Procedures (SOPs), work instructions, and quality documentation.

Requirements Degree-qualified in Engineering, Science, or a related technical discipline.

Minimum of 3 years' experience in a quality-focused role within a regulated manufacturing environment, ideally medical devices or life sciences.

Certified Internal Auditor (ISO 13485) with hands-on experience leading or participating in audits.

Solid working knowledge of equipment validation, risk-based approaches, and statistical analysis.

Strong understanding of non-conformance handling, CAPA processes, and change control.

Meticulous attention to detail with excellent problem-solving and documentation skills.

Ability to communicate clearly across functions and work effectively both independently and as part of a team.

Overview: Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.

Key Responsibilities: Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT) and Performance Qualifications (PQ's) associated with a Syringe Filling Line.

Pre-Approve and Post-Approve validation protocols.

Input into site Validation Master Plans and Standard Operating Procedures (SOP's) Collate and Report on relevant validation data/metrics.

Assist in exceptions and deviation resolution and root cause analysis.

Reviews Validation planning documents detailing overall strategy for the project.

Reviews and Approves Qualification summary reports (QSR) Generates Validation Summary reports.

Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES) Education / Experience: 6+ years experience in Engineering or Validation Technical qualification at third level or equivalent in Engineering.

Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.

Knowledge of safety and GMP requirements.

Demonstrated strong Communication skills Experience using Paperless Qualification Systems is preferred.

Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry Skills: Factory Acceptance Testing Sterile fill finish facility Instillation Verification (IVs) Functional Testing (FTs) Validation Document Review & Approval

A Computer Systems Validation Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical client. This is a 12-month contract. If you have experience with CSV Validation then this is the position for you !Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday) THE ROLE: Integrally involved in the validation of all new computerised equipment, and control systems. Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems. Participates in the change control process advising on CSV issues, as appropriate Hands on role in the development and execution of DQ, IQ, OQ and PQ activities. Ensures projects are managed in compliance with all required Sanofi and legal requirements (Health & Safety, cGMP, construction, environmental etc). Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance. Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation. Ensure that the validation status of equipment and systems are in compliance with cGMP at all times. Maintain validation documentation through the Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans Generate/review/approve execution of the validation/revalidation plan. Review and approval of site change controls Ensure compliance to cGMP at all times Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday) REQUIREMENTS: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector. 2-3 years experience in validation environment Please call Louise Mulligan today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Computer System Validation Engineer CSV Engineer Validation Engineer Benefits: Work From Home

A Computer Systems Validation Engineer is required by Career Wise Recruitment for our Waterford based Pharmaceutical client.

This is a 12-month contract.

If you have experience with CSV Validation then this is the position for you !Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday) THE ROLE: Integrally involved in the validation of all new computerised equipment, and control systems.

Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems.

Participates in the change control process advising on CSV issues, as appropriate Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.

Ensures projects are managed in compliance with all required Sanofi and legal requirements (Health & Safety, c GMP, construction, environmental etc).

Designs, implements and executes validation studies for manufacturing and control equipment.

Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.

Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation.

Ensure that the validation status of equipment and systems are in compliance with c GMP at all times.

Maintain validation documentation through the Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans Generate/review/approve execution of the validation/revalidation plan.

Review and approval of site change controls Ensure compliance to c GMP at all times Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday) REQUIREMENTS: Degree in Science (Chemistry, Micro.

or Pharmacy preferred) or Engineering (Chemical/Mech/Elec 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector.

2-3 years experience in validation environment Please call Louise Mulligan today for further information on or email: Career Wise Recruitment (In Search of Excellence) Established in 1999, Career Wise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow Career Wise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities.

Career Wise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected.

Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Skills: Computer System Validation Engineer CSV Engineer Validation Engineer Benefits: Work From Home

Quality / Validation Engineer - County Westmeath. In this role you will provide Quality Assurance support to ensure the Quality System is of the highest standard with a particular focus on validations and non-conformances. Key Responsibilities: - Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOPs and revision of existing documentation within the quality management system - Carryout internal audits to the ISO 13485 standard. - Partake as a key team member in customer and regulatory audits as required. - Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed. - Monitor vendors and issue NCMRs where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching product. - Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities. - Manage investigation and closure of Validation Deviations, Non-conformances and CAPAs, including support of the investigation processes when not the owner. - Validation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required. Interested applicants should have a Bachelors Degree in Science, Engineering or a related field A minimum of 3 years' experience working at quality engineer level in an ISO 13485 regulated environment. Ideally Internal Auditor qualified to ISO 13485 Experience with equipment validation and statistical analysis. Strong interpersonal, problem solving and attention to detail skills. Skills: quality engineer quality assurance medical device

Quality / Validation Engineer - County Westmeath.

In this role you will provide Quality Assurance support to ensure the Quality System is of the highest standard with a particular focus on validations and non-conformances.

Key Responsibilities: - Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOPs and revision of existing documentation within the quality management system - Carryout internal audits to the ISO 13485 standard.

- Partake as a key team member in customer and regulatory audits as required.

- Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.

- Monitor vendors and issue NCMRs where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching product.

- Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.

- Manage investigation and closure of Validation Deviations, Non-conformances and CAPAs, including support of the investigation processes when not the owner.

- Validation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required.

Interested applicants should have a Bachelors Degree in Science, Engineering or a related field A minimum of 3 years' experience working at quality engineer level in an ISO 13485 regulated environment.

Ideally Internal Auditor qualified to ISO 13485 Experience with equipment validation and statistical analysis.

Strong interpersonal, problem solving and attention to detail skills.

Skills: quality engineer quality assurance medical device

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As a Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth. The Cleaning Validation Engineer will validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. The position is accountable for timely completion of cleaning validation related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility. Essential Duties and Responsibilities Develop and implement cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems. Ensure following EudraLex GMP guidelines. Lead cleaning validation projects for media, buffer, upstream and downstream equipment trains. Collaborate closely with colleagues within the Process Engineering and Validation team and cross functional departments (QA, Manufacturing, Automation and QC). Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required. Own the PEV procedures and plans associated with cleaning validation activities. Prioritise cleaning validation activities in line with the project schedule. Implement product change over assessments. Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required). Identify and implement improvements where feasible to cleaning processes. Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale. Temporary shift working may be required during periods of engineering batch and validation batch execution. Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations. Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections. Will be flexible to take on additional tasks and responsibilities at the discretion of the Process Engineering and Cleaning Validation Lead. Will function as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Technical Competencies Experience of cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility. Experience in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing. Experience A minimum of 8 years cleaning validation experience leading cleaning validation programmes in multiproduct facilities. Knowledge and experience with facility start-up projects (brown field or green field) is advantageous. Experience operating in a fully automated Delta V facility. Excellent communication skills including computer literacy and ability to work independently and in a team. Thorough knowledge of current Good Manufacturing Practices (cGMP). Familiarity with Chromatography and Ultra filtration production operations is desired. Qualifications BEng or BSc in Chemical / Process engineering or relevant science discipline is required. A postgraduate qualification in an engineering or scientific discipline would be advantageous. A qualification in project management would be advantageous. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Good people skills coupled with demonstrated ability to collaborate effectively across functions and sites. Ability to present and successfully defend technical and scientific approaches in both written and verbal form. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities. Results oriented, with the ability to manage multiple priorities in a short period of time. Engage cross functionally in conjunction with a site-based team. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at WuXi Biologics is an equal opportunities employer. Skills: Cleaning Validation cGMP Compliance CIP/COP Systems DeltaV Automation Chromatography Operations Technical Documentation Facility Start-Up Projects Benefits: Bonus Educational assistance Life Assurance Pension VHI