Manufacturing Process Engineer

Manufacturing Process Engineer

Team Horizon is seeking a Manufacturing Process Engineer for a leading manufacturing company in Mayo.

This position reports to the Associate Director of Pharma Maintenance. The successful candidate provides technical assistance for equipment/machinery and all aspects of performance around the manufacturing and aseptic filling of products to customer requirements, FDA, HPRA, EPA and safety standards within budget parameters. You need to have active communication and engagement with many stakeholders within the business (i.e. E&T, Validations, QA, Vendors, Contractors, etc.) to achieve the Site goals.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• Assist with management, engineering, process improvement, equipment reliability, and control system activities.
  
  
• Identify, plan, schedule, manage and communicate on production related projects to all affected stakeholders.
  
  
• Implement lean technologies such as standard work, visualisation boards.
  
  
• Support the business by developing robust process & systems to ensure delivery of effective quality.
  
  
• Ensure that line processes, equipment and materials are maintained to deliver consistent, reliable and predictable process performance and product quality.
  
  
• Develop & implement systems & structure to minimise technical downtime on the line.
  
  
• Resolve and lead technical issues in an effective & timely manner with the technical team to support operations.
  
  
• Drive continuous improvement and process efficiency programs, i.e., MEP, OEE, OPEX, RCA, RCM and productivity output for the business.
  
  
• Manage external vendors and services for equipment and technology
  
  
• Manage the technical documentation, reports, files, logs and records for the department.
  
  
• Assist with the trending, monitoring, performance of equipment and the reduction of unplanned downtime.
  
  
• Help manage, track and monitor the relevant KPIs for the Technical Team.
  
  
• Assist with the trending, monitoring and reduction of repeat deviations associated with the equipment and technology.
  
  
• Generate and approve associated change controls and relevant protocols.
  
  
• Help support the BU during regulatory and compliance audits.
  
  
• Become an SME for the Aseptic Fill and Packaging operations equipment
  
  
• Any other duties as assigned.
  
  What you need to apply:
  
  
• Degree in Mechanical, Electrical or Process Engineering 4+ years experience working in a regulated environment (Pharmaceutical/Medical Device).
  
  
• Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
  
  
• Computer literate with experience of: Maximo, SAP, Trackwise and working with Microsoft Office (Word, Excel, PowerPoint etc.).
  
  
• Strong ability to evaluate, diagnose and troubleshoot problems.
  
  
• Flexibility to respond to issues outside normal business hours.
  
  
• Ability to learn new and different technologies.
  
  
• Experience in high volume automation Pharmaceutical manufacturing environment.
  
  
• Ability to organize workload and work on own initiative