Senior Validation Engineer 12 month contract On site Carlow AMC22531 Start date ASAP I 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 Processes Sterilisation Autoclave & Load Qualification Single Use Technologies SUT and SU components/ manifolds Filter Validation Sterilising and Bioburden reducing Filter Validation & Process Validation Ancillary Equipment for Bio-processing Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
Parenteral Product Visual Inspection (Automated Inspection).
High Potency and ICH Q5 products & containment methodologies Responsibilities: 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 VMP CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures Acting as Validation SME within a team of site representatives as system owner for PQ/ Validation Site 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 approach SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection Working 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.
Skills: Validation CQV Clean Utilities