Website Asset Recruitment
Job ref: 11534
As part of a significant expansion of the Company’s Carlow site, an exciting opportunity has come to be part of the technical transfer of key products for the new facility presently in construction.
As part of the Technical Transfer team you will be responsible for the transfer of a syringe and/or vial product from the existing Carlow line to the newly expanded facility, and a formulation process for the syringe filling process from a US site to Carlow. .
The role will include helping to build and execution of the technical transfer plan for the product. Early engagement with the construction team ensuring that process requirements will be embedded during the construction phase of the project (equipment and facility). Ultimately working towards the goal of completing the Product and Process Qualification batches in 2022.
Reporting to the Technical Transfer Lead and the role will include –
- 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.
- 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 guidance to the process, design and project delivery teams.
- You will be required to Author and review procedures and technical reports required as part of the technical transfer.
- You will be Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
- You will be leading or supporting component criticality assessments for the process.
- Executing activities as part of the Change Management process for the product introduction.
- Effective application of LeanSixSigma and Change Management tools.
- 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.
THE QUALIFICATIONS / EXPERIENCE
- Minimum of 3 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.
- Process or technical transfer experience.
- 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
- 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:
- Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
- 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
- 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. We are looking for around 4 candidates till the end of the year, so new profiles are welcome.