In early 2022 Unispace acquired BioPharma Engineering (BPE) to further develop its passion to support the Life Sciences industry with market-leading design engineering, project management, and workplace/lab consultancy. At Unispace Life Sciences they are focused on engaging the most talented and passionate professionals who believe that everyone should work in an environment that inspires productivity, peak performance, and delivers wellbeing. Across their 50+ global studios, they have a positive work environment that fosters open, collaborative, and supportive cultures populated by highly independent and motivated people. As one of the leading engineering design and project management firms in the industry, Unispace offers a full complement of services including strategy development, design, and construction of laboratories and workplaces focused on Life Sciences.
We are currently looking for a Process Engineer to support our Clare based client. This is an excellent opportunity to join an expanding and sustainably growing business who have just opened a new facility.
- 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
- 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.
- 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).
- Experience of working in a start-up is desirable.
- Experience with Fill Finish operations is desirable.