Our Client a Manufacturing Company in Mayo are looking to recruit a Process Engineer for a 24 month project. The Process Engineer is responsible for providing technical assistance for equipment/machinery and all aspects of performance around the production and packaging of our Clients products to customer requirements, FDA, HPRA, EPA and safety standards within budget parameters.
This will be achieved by active communication and engagement with many stakeholders outside the BU (i.e. E&T, Validations, QA, Vendors, Contractors, etc.) to achieve the BU goals.
This role will be to support the Expansion project and ensure the facility and equipment is commercial ready
Work collaboratively to drive a safe and compliant culture. Coordinate the process improvement, equipment reliability and control system activities.
Identify, plan, schedule, manage and communicate on Technical equipment tasks/improvements to all affected stakeholders.
Implement lean technologies for the Technical team activities such as standard work.
Ensure that line processes, equipment and materials are maintained to deliver consistent, reliable and predictable process performance and product quality.
Support the BU by developing robust process & systems to ensure delivery of effective quality.
Support the BU in new equipment introduction by providing technical input to Project Teams and Documentation such as URS, FS, HDS, SDS etc..
Develop & implement systems & structure to minimise technical downtime on the line.
Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
Resolve technical issues in an effective & timely manner with root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
Drive continuous improvement and process efficiency programs, i.e., OEE, OPEX, RCA, and productivity output for the BU.
Manage external vendors and services for equipment and technology in the BU.
Communication of any concerns about work processes to Management.
Manage the technical documentation, reports, files, logs and records for the Technical Team.
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 and alarms associated with the equipment and technology in the BU. Generate and approve associated change controls and relevant protocols.
Support the BU during regulatory and compliance audits. 50
High level of input into DFMEA & PFMEAs for facility, equipment and process
Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits.
Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
Experience, Qualification and Skills
- Third level qualification in Mechanical, Electrical or Process Engineering
- Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
- Experience in high volume automation manufacturing environment.
- Excellent documentation skills.
- Ability to organize work load and work on own initiative and to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
- Experience: SAP, Coral, Quality software systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).
- Experience: +4 years working in a regulated environment. Identify and understand issues, problems and opportunities whilst providing a viable solution.
- Experience of working on a team, including strong organisational and time management skills.
- Strong ability to evaluate, diagnose and troubleshoot problems.
- Ability to learn new and different technologies.
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