Engineering , Science, Pharmaceutical & Food
Process Engineer – Tech Transfer
PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Carlow.
This is an initial 11-month contract position.
- Execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ’s, 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.
- Provide technical and product guidance to the process, design and project delivery teams.
- Author and review procedures and technical reports as required as part of the technical transfer.
- Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
- Lead and support component criticality assessments for the process and create control strategies.
- Execute activities as part of the Change Management process for the product introduction.
- Apply Lean Six Sigma and Change Management tools to identify process improvements.
- Represent the site in internal collaborations with Technical Transfer and Commercialization teams 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.
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Process or technical transfer experience.
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
- Experience with liaising with other departments – engineering, technical, operations, supply chain, 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***