Automation Process Engineer
Job ID: JOB-11658
Automation Process Engineer
Our client are looking to recruit an Automation Process Engineer to be part of the site engineering team providing process, technical solutions for new / upgrading projects on existing systems and equipment. This will involve interacting with the site operations, EHS, maintenance, utilities, technical and quality teams ensuring that the proposed solutions are acceptable.
Engineering services include Process Development, Process Validation, tool and fixture design, and capacity expansion. The candidate for this role needs to display knowledge of Clean automated manufacturing and Pack operations, have strong process validation and project management experience, to deliver engineering actions on time and within budget. This role will report to the Engineering Manager.
Typical Key Responsibilities:
- Developing project charters, plans, schedules and implementing plans associated with, but not limited to, cost reduction, waste reduction, increased throughput and general operational improvement through the use of Six Sigma statistical methods.
- Design and specification of equipment and systems to current regulations and design standards.
- Determining and justifying capital projects. Specification of new equipment and components by working with capital project team to complete and route through a Corporate stage gate system.
- Writing, conducting, analysing, determining and reporting on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.
- Support validation assessment and validation execution for Clean, Automated and Packaging processes.
- Assist in SAT/FAT as required.
- Troubleshooting daily production and process problems, communicating with plant management team, supervisors and operators regarding run problems, investigates root causes, recommends and implements corrective actions.
- Establishing manufacturing standard operating conditions (SOC) with the appropriate input from the machine operators, supervisors and technical personnel.
- Establishing process methods which meet performance and quality requirements.
- Performing root cause analysis and corrective actions for customer complaints as assigned.
- Competent working knowledge of automation.
- Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
- Competent to effectively communicate manufacturing plans, proposals, results and negotiate options at management levels.
- Excellent report writing, analytical and problem solving skills as well as understanding of root cause analysis methods.
- Skilled user of engineering tools and software packages to design and automate manufacturing processes i.e. AutoCAD, SOLIDWORKS.
- Skilled in writing and execution of Validation protocols, IQ/OQ/PQ, FAT, SAT, CAPA, FMEA, SOP’s, Control Plans
- Familiar with control procedures, such as the Change Notification and Deviation process, and Engineering Specifications.
- Familiar and knowledgeable in Clean, Packaging Operations and new product introductions.
- Ability to liaise directly with clients, maintain and develop the client relationship
- Strong attention to detail and possess excellent documentation and data analysis skills.
- Strong project management and organizational skills and the ability to maintain projects.
- Microsoft Office Suite and Project; Statistical Process Control skills; Desired Experience/Qualifications:
- 5-7 years’ manufacturing experience.
- Automation AND/OR Medical devise experience desirable.
- B.Sc. in Mechanical, Industrial or other Engineering Science and demonstrated multiple years of Validation experience
- Requirement for ISO13485 Medical Device and Automation experience
- Handling project assignments of large scope and complexity and able to prioritize and complete work in a timely manner.
For further information on this Automation Process Engineer role in Galway please contact Ciaran Fahy on 0874108620/ email@example.com
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