10339 – Process Engineer – Carlow Contractor

Purpose:

As part of this Technical Transfer Lead role, the Process Engineer will be responsible for the transfer of a syringe product from the existing line to the newly expanded facility, and a formulation process from a US site to Carlow. As part of your role you will be leading a technical team to ensure that all aspects of the technical transfer process will be adhered to. As part of this role you will be the key point of contact on site for all aspects of the technical transfer which will require liaising with internal and external stakeholders. The role will be required to help form the teams and build the technical transfer plan for the product. This will also ensure that process requirements will be embedded during the construction phase of the project (equipment and facility). Ultimately the Product and Process Qualification batches are planned mid 2022 with regulatory approval in 2023. Within this role you will be acting as the technical transfer lead for the syringe product, reporting within the Technical Engineering department.

Responsibilities:

• Lead and execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, etc.
• Plan, schedule and resource the complete technical transfer programme and then to lead the team to successful completion of the product introduction to regulatory approval and initiation of commercial production.
• Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
• Providing technical and product oversight to the process, design and project delivery teams and coaching to associate staff within the assigned suite.
• You and your team will be required to Author and review procedures and technical reports required as part of the technical transfer.
• You and your team will be Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Supporting regulatory submissions, in particular driving the post approval change management process being adopted for this product.
• Owning Change Management process for the product introduction.
• Effective application of LeanSixSigma and Change Management tools 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 in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices.
• 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.

Minimum Qualifications and Experience:

• Minimum of 10 years directly related experience in academia, pharmaceutical or biotechnology industry.
• A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• 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.
• Excellent oral and written communication skills.
• 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.
• Show ambition and drive to develop and advance within the role.
• Process or technical transfer experience on Large Scale Projects.
• Leadership experience managing a team to deliver short and long term objectives as part of a project or program.
• Project Management experience / training in use of Project Management tools.
• SME on Equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
• Experience with liaising with other departments – engineering, technical, operations, QA and Regulatory Affairs.
• Experience with sterile processing and sterilisation technologies.
• Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
• 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;
  • Visual Inspection technologies for Vial / Syringe.
  • Vial / Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
  • New facility brown/ green field facility experience.
  • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.