Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract.
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:
* 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.
THE TIMEFRAME
* 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.
* Managing the workload and providing coaching for a team of Validation Engineers within the assigned area.
* 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.
The role will include
* Work within a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project.
* 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).
* Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
* Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
* 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.
Effective application of LeanSixSigma and Change Management tools in the Validation group by:
* Leading by example in achieving results by using industry standard tools and processes.
* Facilitate problem solving & risk assessment (FMEA) projects/meeting.
* Make problems visible and strive for continuous improvement.
* Serving as a key member during internal audits and external inspections/audits.
* Supporting alignment and knowledge exchange with development organizations, other commercial nodes, and external manufacturing partners.
* Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
* 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.
* Keep up to date with scientific and technical developments, best practices and attend seminars as required.
* Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
* Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
THE QUALIFICATIONS / EXPERIENCE
Preferred Experience and Skills:
* 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.
Ideally
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.
* The successful candidate will also have a proven track record in delivering excellence.
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