Process Engineer – Shannon – Permanent!
Exciting opportunity for a Process Engineer looking for the next step in their career with a well-respected company in Galway. The ideal candidate will hold a bachelor's degree with relevant experience.
The ideal candidate will have a comprehensive practical and theoretical background in a wide range of Biopharmaceutical equipment and manufacturing processes. They should be familiar with computerized equipment systems and principles of data integrity, including assessment and verification. Experience in commissioning and qualifying process equipment and utilities is necessary. They should possess problem-solving skills, leadership abilities, self-motivation, effective planning and organizing capabilities, professionalism, innovative thinking, and strong communication skills both verbally and in writing.
For further information or a confidential discussion please contact me!
- Support Capital project design and review activities, particularly Single use equipment items & setup.
- Support Process Technical transfer activities; including Design of Experiments, Single-Use items specifications development for manufacturing use and ongoing Process FMEA activities.
- Coordination of vendor activities for Commissioning & Qualification, Maintenance & Calibration and/or process improvements.
- Assist with the implementation and development of applicable engineering specifications and standards.
- Provide SME input to on-site SH&E programmes including process and task risk assessments, investigations and/or any other related aspect of safety improvement performed by the process engineer.
- Assist with the implementation, maintenance and measurement of a framework for compliance and continuous improvement in quality performance. Exhibit a right-first-time ethos while sustaining compliance to statutory, regulatory and company standards, procedures and systems.
- Develop and manage strong relationships across teams to remove barriers, or time lags while performing effectively within own working groups to achieve favourable outcomes for the business.
- Assist with the identification and implementation of technology based and work practice solutions designed to reduce waste and overall cost.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.
Education and Experience required:
- Qualified to Degree Level in a related Engineering or Science discipline.
- Min 5 years’ Experience of working within a Biopharmaceutical environment in a Process engineering role.
- Cleanroom working knowledge is essential.
- Knowledge of biopharmaceutical process operations including Media & Buffer prep, Upstream & Downstream (i.e. Single Use Bioreactors, Centrifuges, UF/DF, TFF) is essential.
- Must be proficient in English (verbal & written).
For further information or a confidential discussion please contact