Job description
A world leading pharma organisation are seeking a Process Engineer to join their engineering team in Westport, Co. Mayo. The Process Engineer is responsible for providing technical assistance for equipment/machinery and all aspects of performance around the production and packaging of products to meet customer requirements, FDA, HPRA, EPA and safety standards.
Roles and Responsibilities
- 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.
- Ensuring systems, equipment, and products operate at optimal levels and meet Business Unit (BU) needs by preventing failures and maximizing uptime
- Analyse equipment failure data, conduct root cause analysis, develop and implement new procedures and processes to prevent reoccurrence
- Implement lean technologies such as standard work, visualisation boards.
- Support the BU by developing robust process and 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 technical issues in an effective & timely manner with the technical team to support operations.
- Drive continuous improvement and process efficiency programs, i.e., OEE, OPEX, RCA, RCM and productivity output for the BU.
- Manage external vendors and services for equipment and technology in the BU along with Manufacturing.
- Manage technical documentation, reports, files, logs and records for the BU.
- 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 in the BU. Generate and approve associated change controls and relevant protocols.
- Help support the BU during regulatory and compliance audits.
Qualifications
- Third level qualification in Mechanical, Electrical or Process Engineering
- 4+ years experience working in high volume automated manufacturing environment performing a similar role is essential. Pharmaceutical industry experience is preferred.
- Detailed knowledge of regulatory requirements in a pharmaceutical GMP environment.
- Excellent documentation skills.
- Excellent digital literacy with experience using Maximo, One Vault, Quality software and Microsoft Office (Word, Excel, PowerPoint etc.).
