Engineering & Electronics
Validation Team Lead
PE Global is currently recruiting for a Validation Lead on behalf of our client based in Carlow. This is an initial 11-month contract role.
- An exciting opportunity has come to join the science, engineering/ manufacturing & commercialisation team to support the transition of a new high potency facility from construction, project phase to a fully operational facility delivering life-saving products to patients.
- The role will require the leadership of an experienced, energetic, and committed technical lead with broad experience including the below areas.
- Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
- Vial and Syringe Filling operations – Glass handling, Tray & Tub handling, Drug Product Filling.
- Formulation processing using Delta V including Transfer Panel and Utility Qualification.
- Parenteral Product Visual Inspection (Automated Inspection).
- Cleaning Validation in Biotech facility & Cleaning Processes
- Sterilisation Validation – Autoclave & Load Qualification
- Single Use Technologies – SUT
- High Potency and OEB5 products & containment methodologies
- The successful candidate should have demonstrated experience in at least five of these key areas.
- The successful candidate will be involved in the project from Detailed Design, Construction, Site Acceptance Test (SAT) at the earliest, 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 working on;
- Aligning new facility introduction with Validation approach across site and author and owner for project VMP
- CQV approver for C&Q and developing Validation strategy documents and project plans and procedures
- Acting as Validation Lead for team of site representatives as system owners for PQ/ Validation
- Factory/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 Validation/ PQ executions
- Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment
- Responsible for cycle development, PQ and validation programmes. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
- Performance Qualification – Responsibility for / Execution of Performance Qualification testing for assigned process equipment
- 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
- Within the role you will be acting as a technical SME & Validation Lead reporting within Technical Engineering at Tier 2 and Tier 3 level as required.
The role will include –
- Define scope and build a team of Validation professionals from ‘Intern’ level to P4 specialist to own and execute the Validation & PQ aspects of the project
- Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, ensuring team representation at SAT (remotely and/ or in person) and design reviews to represent site Validation interests.
- 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 SOPs 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.
- 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
- 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.
- Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
Education and Experience:
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
- This role requires an experienced individual with a minimum of 10 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- Minimum 5 years process equipment C&Q/ Validation experience on Large Scale Projects or commercial operations.
- SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Containment Isolators/Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
- 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.
- Shipping Qualification.
- New facility brown/ green field facility experience, or training & developing a team within a commercial manufacturing environment
- Small equipment qualification and validation; Single Use Technologies, FITs, Scales, Tube Sealers/ Welders
- 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.
- 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 Holly on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***