An exciting opportunity has arisen for a Validation Lead to support the transition of a new high potency facility in the midlands from construction, project phase to a fully operational facility. 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.
- Leadership of an experienced, energetic, and committed technical lead with broad experience including Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems, Glass handling, Tray & Tub handling, Drug Product Filling.
- Formulation processing using DeltaV 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.
- Managing the workload and providing coaching for a team of Validation Engineers within the assigned area.
- 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.
- Installation to Mechanically Complete – C&Q Oversight for assigned process equipment.
- 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 the Company’s requirements to ensure compliance, safety and reliable supply to our customers.
- 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.
- Drive compliance with the Company’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- 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.
- 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.
- 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.
- Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
Qualifications & Experience:
- 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.
- 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.
- Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI desirable but not essential.
- Clean Utilities and HVAC system Qualification desirable but not essential.
- Shipping Qualification desirable but not essential.
- New facility brown/ green field facility experience, or training & developing a team within a commercial manufacturing environment desirable but not essential.
- Small equipment qualification and validation; Single Use Technologies, FITs, Scales, Tube Sealers/ Welders desirable but not essential.
- Experience with sterile processing and sterilisation technologies is advantageous desirable but not essential.
- Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus desirable but not essential.
- Use of Delta V and associated new Phase development and Qualification works desirable but not essential.
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