Posted: 15 January
Offer description
Job Description
An exciting opportunity has come to join the science, engineering/manufacturing & commercialisation team to support the transition of the new facility from construction and project phase to a commercialisation of fully operational facility delivering life-saving products to patients.
You will be acting as a technical SME and Senior CQ/Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required. The role requires leadership of an experienced Senior/Lead Engineering (CQV/Technical Engineer) with broad experience in Vial and Syringe Filling operations and the following key areas:
* 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
The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.
Responsibilities:
* 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
* 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 Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort Act as SME on the process & equipment within the assigned area Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area Implementing the requirements as outlined in the site & project Validation Master Plan(s) Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/or validation counterparts Supporting regulatory submissions as required Owning Change Management process for Equipment introduction within the assigned area for qualification/validation up to PQ stage Serving as a key member during internal audits and external inspections/audits Represent the site as required in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation and C&Q to include sharing of best practices in C&Q/Validation and investigation activities
Education and Experience:
* With relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification, the successful candidate will also have a proven track record in delivering excellence
* 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
