Quality , Science, Pharmaceutical & Food
- Shannon, County Clare, Ireland
PE Global is currently recruiting for a Project Engineer for our biopharmaceutical client in County Clare. This is an initial 12-month contract, hybrid role.
About the job
The role is required due to the site having set up its internal Manufacturing Facility for Advanced Therapies (Gene Therapy viral vectors) in Shannon. The facility is planned to manufacture Phase 3 and commercial supply for its in-house programmes. The facility requires a Project Engineer (Biologics) to support the manufacturing organisation, it’s day-to-day site operations, process improvements as well as support to CapEx and Technical Transfer project activities across the site.
This is a fast-track programme, therefore the role requires the ability to be flexible and covers a very broad remit.
- 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
Key Performance Indicators
- Deliver sustainable improvements exhibited via KPIs assigned to engineering and aligned with safety and quality compliance policies.
- Support project deliverables, including on-time and right-quality-level requirements.
- Contribute proactively to the wider development of an evolving engineering team and its effectiveness to add value in a setting focused on compliance and ultimately patients benefit.
- The process engineer shall have pedigree working in a highly regulated cleanroom environment in the bioprocessing sector.
Key Job Competencies
- Comprehensive practical and theoretical background in a wide range of Biopharmaceutical equipment and manufacturing processes. Cleanroom working knowledge is essential. Experience of working in a start-up is desirable.
- Min 5 years’ Experience of working within a Biopharmaceutical environment in a Process engineering role.
- Knowledge of biopharmaceutical process operations including Media & Buffer prep, Upstream & Downstream (i.e. Single Use Bioreactors, Centrifuges, UF/DF, TFF) is essential. Experience with Fill Finish operations is desirable.
- Familiarity with computerised equipment systems and the principles of data integrity, including assessment and verification for new and existing equipment.
- Experience with the requirements of commissioning and qualification of process equipment and utilities items.
- Problem Solver – Identifies and resolves problems in a structured and timely manner; gathers and analyses information; develops solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
- Planning & Organizing – prioritizes and plans work activities; uses time efficiently; sets goals and objectives; organizes or schedules others and their tasks; develops realistic plans.
- Professional – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless; accepts responsibility for own actions; follows through on commitments.
- Innovator – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Communication – speaks clearly and persuasively; listens and seeks clarification when needed; good presentation skills; participates effectively in meetings. Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and decipher written information.
Education – Qualified to Degree Level in a related Engineering or Science discipline.
Languages – Must be proficient in English (Speaking & Writing)
Experience – Biopharmaceutical Manufacturing (Cell & Gene Therapy) preferred.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Paul Wheatley on 083 094 0199 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***