Process Engineer

Summary:
Our client is a biopharmaceutical company based in Cork, looking for a Process Engineer who will be responsible for providing engineering support to the Vaccine production in relation to the process equipment. This includes trouble shooting, investigating and documenting process equipment issues. The Day Process engineer will own all Quality and Safety investigations handed over from the shift. Own any resulting CAPAs relating to process equipment. Identify and assist in the implementation of equipment process improvements and optimization opportunities.

Responsibilities:

• Continually evaluate and optimize manufacturing processes to enhance efficiency, reduce waste, and minimize costs.
• Analyse data, collaborate with cross-functional teams, and identify areas for improvement to achieve operational excellence.
• Play a critical role in identifying and resolving issues in manufacturing processes.
• Analyse data, conduct root cause analysis, and develop and implement solutions to improve process performance and resolve bottlenecks.
• Responsible for creating and maintaining maintenance plans on SAP, and engineering standard operating procedures (SOPs), work instructions, and process flow diagrams.
• Actively participate in continuous improvement initiatives and lean manufacturing practices.
• Collaborate with cross-functional teams to implement process improvements, such as implementing automation, reducing cycle times, and enhancing product quality.
• Work closely with quality teams to ensure that manufacturing processes comply with quality standards and regulations.
• QN and CAPA owner.
• Conduct audits with the quality team to identify opportunities for improvement.
• Lead or participate in projects related to process improvement, new product introduction, cost reduction, or capacity expansion.
• Coordinate project activities, set timelines, allocate resources, and ensure successful project implementation.
• Works closely with the EHS teams to ensure EHS compliance. Completes EHS investigation, CAPA owner.
• Identify opportunities for process improvements, cost reductions, and energy efficiency enhancements related to mechanical systems and equipment.

Qualifications & Experience:

• Degree or 3rd level qualification (Science, Engineering), Masters preferred.
• At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in an operations environment.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc).
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Demonstrated leadership and change management skills with a continuous improvement focus.
• Desirable project management qualification such as Project Management Professional etc.
• Desirable evidence of Continuous Professional Development.
• Preference Lean Six Sigma Black Belt.
• Demonstrated ability to fully realize change and improvement initiatives.