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Job ID: JOB-13426
The Process Engineer is responsible for providing engineering support to existing and new processes to meet Quality, Service and Cost Objectives at the Aerogen Shannon Manufacturing facility, with frequent travel required between Galway and Shannon sites.

This role is complemented with support from the Production, Supply Chain and Quality functions.

Other activities may be assigned by the Section Leader Core Operations Engineering.

What are the key responsibilities? ​

• Provide subject matter expertise on Aerogen’s process technologies to support key business metrics.

• Responsible for reporting on yield, OEE metrics and product failure investigation.

• Support the introduction of new products and process technology through Process Development and Validation.

• Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout.

• Lead or actively participate in cross-functional teams to ensure that continuous improvement projects are completed in a timely and efficient manner.

• Preparation and maintenance of manufacturing specifications for specific projects.

• Ensure effective closure on Quality System documents (Audit Actions, NC’s, CAPA’s, etc..).

• Ensure all production equipment, processes and work areas meet Health & Safety requirements through the completion of the required documentation.

• Partners with all customer, FDA and NSAI audits when required.

• Assists, as necessary, other functions to achieve timely product shipments.

• Perform other assigned tasks as directed by Manager. ​ What education and experience are required? ​

• Degree in Engineering, Technology or Science or an equivalent qualification

• 4 years’ experience within ISO13485 registered medical device industry. ​ What key skills will make you great at the role?​

• Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements as these apply to this role.

• Self-starter with ability to work independently under pressure and react quickly to changing priorities.

• Strong team member with the ability to identify and drive implementation of innovative quality improvements.

• Meticulous attention to detail while also conveying a sense of urgency

• Effective communication and interpersonal skills; written, verbal and presentation. Must have the ability to communicate effectively and concisely at all levels of the company.

• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.

• Ability to lead Project Teams and proactively contribute to continuous improvement initiatives.

• Strong Problem-Solving capability, possessing a demonstrated capacity to identify problem root causes, deliver solutions, risk assess.

• Data analysis and numeric skills with the ability to evaluate, analyse and present data.

• Ability to create, plan and coordinate changes to product and process with cross functional teams, vendors and customers.

• Work closely with Quality, Production and Supply Chain departments to establish and identify the conditions that underpin Reliable Equipment and Manufacturing Processes.

• Proficiency in Microsoft Office software.

• Flexibility to work between different Aerogen sites

Shauna Brady

JOB-13426

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