17384-Validation Lead- Carlow Contractor

This is an 11- month initial contract.

Purpose

As part of a significant expansion, an exciting opportunity has come to join the science, engineering/ manufacturing & commercialization team to support the transition of a new high potency facility from the construction, and 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 in 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 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
• 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.

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 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 a 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 a 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 programs. Ensure that objectives are effectively achieved, consistent with Merck’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 the 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 Merck 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.
• Work collaboratively to lead a safe and compliant culture in Carlow.
• Within the role, you will be acting as a technical SME & Validation Lead reporting within Technical Engineering at Tier 2 and Tier 3 levels as required.
• 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 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 the 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/meetings.
• 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, and 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.

Requirements

• Minimum 5 years of 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.
• 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, and authoring documents subject to regulatory inspection.
• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping, and CCI.