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Validation Engineer
4 days ago
This is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject matter Expert (SME) in supporting the execution of the qualification studies relevant to the site thermal systems supporting aseptic manufacturing. You will be responsible for: Validation documentation drafting, reviewing and approving Validation documentation. Manage contractors as per site contractor management procedures. Oversee, witness, and execute where required requalification activities on site Thermal systems. Participate in Validation Risk Assessments to determine the level of testing required for equipment changes or new equipment. Support sustaining and project Validation activities across Drug Substance and Drug Product Areas Input into the core aspects of Operations, Qualification and Validation SOP's where required. Maintaining hardcopy records in Document control archive, including reconciliation of Documentation. Leading or supporting validation deviations as they occur. Supporting closeout of investigation actions for Validation team. Ensure Requalification and Periodic Review activities are completed in a timely manner. Provide support in areas of commissioning and qualification of HVAC systems where required. Report / present out on project updates as required. Encourage and sustain a high safety culture and performance within the Validation teams. You will need to have: 5 years+ relevant experience working in a Validation role in the Pharmaceutical / Biotechnology industry. Good knowledge of EN285 and the kill kinetics of Stem Sterilization systems. Good knowledge of CTUs thermal mapping requirements. Demonstrated ability to work effectively with various departments and resolve issues in structured manner. Strong technical capabilities, communication skills, teamwork abilities and initiative. Proven ability to work well as part of a team & on own. We would prefer for you to have: Goods understanding of the requirements of ISO 14644 and how it supports aseptic manufacturing. Good Knowledge of VHP (Vaporized Hydrogen Peroxide decontamination systems) Understanding of the Aseptic Manufacturing processes Education Technical Degree in Engineering/Life Sciences Skills: Thermal Validation requalification Hvac
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Validation Engineer
7 days ago
Dublin, Ireland Recruitment by Aphex Group Full timeThis is a 12-month contract and is an onsite role. Purpose 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 Onsite position. Once the projects are at certain stages there will be opportunities throughout to...
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Validation Engineer
14 hours ago
Dublin, Ireland Morgan McKinley Full timeAbout the Job: An exciting opportunity has arisen for a Validation Engineer to join my client's dynamic validation team. This role focuses on managing the validation of computerized systems, specifically in the medical device industry. Key responsibilities include developing and reviewing validation documentation in alignment with industry standards and...
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Senior Validation Engineer
2 weeks ago
Dublin, Ireland Embecta Full timeembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...
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Senior Validation Engineer
2 days ago
Dublin, Ireland Embecta Full timeembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...
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Validation Engineer
3 weeks ago
Dublin, Ireland Claran Consultants Ltd Full timeThis is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject...
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Senior Validation Engineer
2 weeks ago
Dublin, Ireland Life Science Recruitment Full timeWe’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning,...
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[High Salary] Senior Validation Engineer
14 hours ago
Dublin, Ireland Morgan McKinley Full timeValidation Engineer - Sterile Fill Finish We are looking for an experienced Validation Engineer to support CQV activities for in a sterile fill finish facility. This is a fantastic opportunity to work in a GMP-compliant environment, ensuring validation activities meet quality and regulatory requirements. Key Responsibilities: ✔ Develop, execute, and...
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Validation Manager
5 days ago
Dublin, Ireland Amgen SA Full timeAseptic Processing Validation Manager The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Manager for the HVAC /AVS (Airflow...
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▷ High Salary! Validation Engineer New
2 weeks ago
Dublin, Ireland CPL Full timeOn behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position site based in North Wicklow/South Dublin. Reports to Maintenance, Engineering and Validation Manager Essential responsibilities - Compilation and execution of validation protocols - Compilation of...
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Senior HVAC/Validation Engineer
6 days ago
Dublin, Ireland Syntech Recruitment Ltd Full timeSenior HVAC/Validation Engineer Location: Dublin, IrelandSalary: €65,000 - €70,000 + OvertimeJob Type: Full-time, Permanent Benefits:Paid overtimeCompany van, fuel card, laptop and mobile providedContinuous development and training opportunities25 days holiday, with the option to buy/sell additional daysFlexible working optionsPrivate healthcarePension...
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Senior QA Specialist
3 weeks ago
Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Quality Assurance Specialist (Validation) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7 years of experience working in the pharmaceutical or biotechnology industry and are ready for...
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Senior QA Specialist
2 days ago
Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Quality Assurance Specialist (Validation) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7 years of experience working in the pharmaceutical or biotechnology industry and are ready for...
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QA System and Validation
2 weeks ago
Dublin, Ireland CPL Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: • Assessment of changes for GMP compliance in accordance with site change control procedure for...
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QA System and Validation Specialist
2 weeks ago
Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
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Apply Now: Validation Manager
2 days ago
Dublin, Ireland Amgen Full timeAseptic Processing Validation Manager The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Manager for the HVAC /AVS (Airflow...
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Senior Validation Professional- Medical Device
2 weeks ago
Dublin, Ireland Brightwater Full timeSenior Validation Professional-Medical Device About the Company My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life. About the Position This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical...
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Cleaning Validation Specialist
7 days ago
Dublin, Ireland Cpl Healthcare Full timeCLEANING VALIDATION SPECIALIST Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle. Job Purpose: Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...
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Cleaning Validation Specialist
2 weeks ago
Dublin, Ireland CPL Full timeCLEANING VALIDATION SPECIALIST Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle. Job Purpose: Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...
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Senior QA Validation Specialist
2 days ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...
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Dublin, Ireland Amazon Full timeHardware Design Engineer, Amazon Ring Vietnam Design Center Job ID: 2794284 | Amazon Corporate Services Vietnam Company Limited Ring is a leader in developing security products, such as Video Doorbells, Spotlights, and Cameras. Our Product Integrity team aims to develop reliable and robust products that delight our customers. Ring is seeking a Hardware...