Validation Engineer
12 hours ago
This 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 do some hybrid work. Responsibilities Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT) and Performance Qualifications (PQs) associated with a Syringe Filling Line. Pre-Approve and Post-Approve validation protocols. Input into site Validation Master Plans and Standard Operating Procedures (SOPs) 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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES Qualifications 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: Sterile Fill Finish Experience FAT IVs FTs SAT PQs
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Senior Validation Engineer
1 week 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
2 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
1 week 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! Validation Engineer New
1 week 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 QA Specialist
2 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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QA System and Validation
7 days 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
1 week 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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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
1 week 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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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...
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(15h Left) Validation Engineer II
1 week ago
Dublin, Ireland Jabil Circuit Full timeAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...
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[3 Days Left] Cleaning Validation Specialist
1 week ago
Dublin, Ireland Life Science Recruitment Full timeWe’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. 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. Execute cleaning cycle development and PQ of equipment. 2. Writing and adhering to validation strategies,...
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Senior QA Validation Specialist
19 hours 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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Commissioning Engineer
2 weeks ago
Dublin, Ireland Headcount Solutions Limited Full timeCommissioning EngineerThe CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of...
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CQV Engineer
4 days ago
Dublin, Ireland Next Generation Recruitment Full timeThe CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality...
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Process Engineer
1 week ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeProcess Engineer - Pharmaceuticals - 11-Month Contract With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Carlow. This is a fantastic opportunity to work on a state-of-the-art...
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Lead Project Engineer
1 week ago
Dublin, Ireland Life Science Recruitment Full timeProject Engineer 11 month contract On site - Carlow I am currently looking for a Project Engineer to join the Technical Engineering Department for a growing biopharmaceutical manufacturer in Carlow. You will help lead Process Improvements, capital projects and lean projects across multiple functions. The ideal candidate will have experience as a Capital...
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Project Engineer
1 week ago
Dublin, Ireland Team Horizon Full timeProject EngineerTeam Horizon is seeking a Project Engineer for a leading pharmaceutical company based in West Dublin. Supporting the Capital Projects Team with site-based projects for Oral Solid Dose Manufacturing, Facilities and Packaging operations.Why you should apply: * You enjoy working on exciting projects and want to work with a global manufacturing...
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Automation Engineer
5 days ago
Dublin, Ireland Grifols, S.A Full timeArea: Maintenance / General Services / Facilities Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in...
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Production Support Engineer
5 days ago
Dublin, Ireland Cpl Healthcare Full timeJO-2412-544723 Our client, based in Swords, requires a hands-on Production Support Engineer to join their team. This is an exciting opportunity to grow your career with a global company specializing in precision engineering. Role 1. Support manufacturing processes and provide process improvements to existing products. 2. Define and validate manufacturing...