Senior CQV Engineer

The role:

PE Global is currently recruiting for a Senior CQV Engineer on behalf of a leading pharmaceutical company based in Carlow. This is an initial 12-month contract role.

Description:

• An exciting opportunity has come to join the science, engineering/ manufacturing & commercialisation team to support the transition of the new facility from construction & project phase to a commercialisation of fully operational facility delivering life-saving products to patients.
• Within the role you will be acting as a technical SME & Senior CQ/ Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required.

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.

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
• 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.
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***