22531-Validation Engineer-Carlow Contractor

This is a 12-month contract with a view to extension.

Purpose

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 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.

Levels of responsibility will vary during this timeframe as outlined below –

• 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 the 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.

Responsibilities

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 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.

With a high degree of technical flexibility, work across diverse areas within QC

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance. May contribute to regulatory filings.
• May represent the department/organization on various teams. May train others.
• May interact with outside resources

Requirements

• 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.
• This role requires an experienced individual with a minimum of 6 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
• The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
• S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• 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.
• The candidate will also show ambition and drive to develop and advance within the role.
• 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.
• 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.