Process Engineer job in Limerick, Republic of Ireland

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Job type: Permanent

Discipline: Manufacturing, Validation, Packaging

Location: Ireland

This vacancy has now expired. Please see similar roles below...

Proclinical is currently seeking a highly skilled and experienced Process Engineer with a cutting-edge biotech company. This role is on a permanent basis and is located in Limerick, Ireland.

Responsibilities:

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.
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 Skills and Requirements:

Comprehensive practical and theoretical background in a wide range of Biopharmaceutical equipment and manufacturing processes.
Familiarity with computerized 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 - verbally communicates 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.
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.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at +44 203 0590923.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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