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Senior validation engineer

Life Science Recruitment
Validation engineer
Posted: 20 August
Offer description

Did you know that your Internet Explorer is out of date?To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.Name:Surname:Email:Phone:Cv:Salary Expectations:Education:Experience:Current Location:Notice Period:Write here your cover note:If you would like us to create a jobseeker account for you, giving you access toaccount management, job alerts and one-click applications, then please tick this boxIf you are having difficulty you can always email your cv to applications@lifescience.ieSenior Validation Engineer12 month contractOn site CarlowAMC22531Start date ASAPI am looking for an experienced Equipment Validation Engineer to support the transition of a new biomanufacturing facility from project phase to a fully operational manufacturing facility.This role would be suitable for a CQV/lead Engineer with 6+ years experience in Vial and Syringe Filling operations. The scope of this role will involve Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.Cleaning Validation in Biotech facility & Cleaning ProcessesSingle Use Technologies – SUT and SU components/ manifoldsFilter Validation – Sterilising and Bioburden reducing Filter Validation & Process ValidationAncillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity TestingFormulation processing using DeltaV including Transfer Panel and Utility Qualification.Parenteral Product Visual Inspection (Automated Inspection).High Potency and ICH Q5 products & containment methodologiesSenior Validation Engineer12 month contractOn site CarlowAMC22531Start date ASAPI am looking for an experienced Equipment Validation Engineer to support the transition of a new biomanufacturing facility from project phase to a fully operational manufacturing facility.This role would be suitable for a CQV/lead Engineer with 6+ years experience in Vial and Syringe Filling operations. The scope of this role will involve Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.Cleaning Validation in Biotech facility & Cleaning ProcessesSterilisation – Autoclave & Load QualificationSingle Use Technologies – SUT and SU components/ manifoldsFilter Validation – Sterilising and Bioburden reducing Filter Validation & Process ValidationAncillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity TestingFormulation processing using DeltaV including Transfer Panel and Utility Qualification.Parenteral Product Visual Inspection (Automated Inspection).High Potency and ICH Q5 products & containment methodologiesResponsibilities:The successful candidate will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.Levels of responsibility will vary during this timeframe as outlined below –Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on;Aligning new facility introduction with Validation approach across Carlow site and review and approval of project VMPCQV approver for C&Q documents and input to Validation strategy documents and project plans and proceduresActing as Validation SME within a team of site representatives as system owner for PQ/ ValidationSite Acceptance Test – Attendance, hands-on support and C&Q Oversight for assigned process equipment.Working with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/ PQ executions.Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment.Cycle Development – Execution of Cycle Development pre and post OQ phases for assigned process equipment.Performance Qualification – Responsibility for / Execution of Performance Qualification testing for assigned process equipment.Liaising with Tech Transfer team to ensure product requirements are met.Ownership of updates to Technical SOPs related to Validation and assigned process systems.Managing site change controls as part of QMS implementation of the new facility as required.Ensuring that PQ and Validation are aligned with the regulatory & market requirements for filing the new facility and product licensure at the close out of the project.Required Experience:Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approachSME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & InspectionWorking knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.Desirable but not essential;Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.Clean Utilities and HVAC system Qualification.New facility brown/ green field facility introduction experience, or training & developing a team within a commercial manufacturing environment.Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.Experience with sterile processing and sterilisation technologies is advantageous.Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.Project Management experience / training in use of Project Management tools and software tools.Use of Delta V and associated new Phase development and Qualification works.Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information.
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