Senior Validation Engineer

Role Summary:

• A new exciting opportunity now exists on our client’s pharmaceutical Co. Carlow site for a Senior Validation Engineer to join the science, engineering/ manufacturing & commercialisation team to support the transition of their new facility from construction & project phase to a commercialisation of fully operational facility.
• 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.

Core Duties and Responsibilities:

• 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.

Minimum Qualifications and Experience:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification, with a proven track record in delivering excellence.
• Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry (academia, pharmaceutical or biotechnology) industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
• Self-starter and results-focused with strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
• Demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
• 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.
• The candidate will also show ambition and drive to develop and advance within the role.
• 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.

Please note, we do not require agency assistance with this role.