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Automation Process Engineer
- Full Time
Celestica enables the world’s best brands. Through our unrivalled customer-centric approach, we partner with leading companies in aerospace and defence, communications, enterprise, healthtech, industrial, capital equipment, and smart energy to deliver solutions for their most complex challenges. With talented teams across North America, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica Galway are a leader in automated manufacturing services with proven expertise in delivering scalable manufacturing solutions throughout the product lifecycle. Celestica Galway supports and provides Automated Technology Solutions & Healthtech Solutions for a number of customers including the Medical Device space.
This position offers a great opportunity for an Automation Process Engineer to work in a dynamic and challenging environment. This role will support a number of customers across the business in the Automated Technology Solutions & Healthtech (Medical Device) market so we are inviting candidates that have experience in Automated Pharmaceutical or Medical Devices.
The Automation Process Engineer will 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.
- 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.
- Manage the maintenance and calibration of critical equipment-systems
- Competent working knowledge of automation.
- Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
- Literacy of engineering drawings for geometric dimensioning and tolerance.
- 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
- Ability to engage and communicate effectively with design disciplines.
- 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;
- Working knowledge of identification of hazards and risk assessment
- Excellent interpersonal & communication skills.
- Minimum 5-10 years’ Process Automation experience.
- 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.
This role may include extensive International Travel depending on program assignment