Process Engineer

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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