Engineering Technician

Recruitment by Aphex; Waterford; On-site; EUR 52,000 - 72,000; Full time

Job summary

Recruitment by Aphex is seeking a capable Manufacturing Engineer to support quality and validation in a medical manufacturing environment. You will develop and maintain processes, design testing methods, and ensure compliance with ISO, FDA and GMP standards.

The role requires a Level 7 Engineering degree, 3+ years in medical manufacturing, strong leadership, fault-finding, and ability to work with cross-functional teams. Excellent documentation and communication are essential.

Qualifications

• Degree in Engineering or Technical Science (Level 7) required.
• 3+ years in a medical manufacturing environment preferred.
• Knowledge of ISO, FDA, GMP and six sigma requirements.
• PLC programming desirable.

Responsibilities

• Support quality of manufacturing and validation processes across management systems (Quality, HR, OHS).
• Develop and maintain manufacturing processes by analyzing requirements and testing methods.

Skills

Leadership

Faultfinding

Interpersonal skills

Communication skills

Teamwork

Quality focus

Education

Ordinary Degree (Level 7) in Engineering or Technical Science

Tools

PLC Programming

Job description

Responsibilities

• Support the quality of the manufacturing and validation processes through the Company's management systems: Quality, HR, OHS.
• Develop and maintain manufacturing processes by analysing product requirements, researching, designing, modifying, and testing manufacturing methods and equipment.
• Evaluate processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
• Assure product and process quality by designing testing methods, testing finished product and process capabilities, establishing standards, confirming manufacturing process.
• Improve manufacturing efficiency by analysing and planning work flow, space requirements and equipment layout.
• Develop manufacturing technical capabilities and skills to ensure ongoing process requirements can be effectively achieved and continually improved.
• Provide manufacturing decision making information by identifying cost saving initiatives in labour and material costs and consumption and process improvements.
• Keep equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures.
• Prepare technical documentation such as SOPs, safety programmes, validation protocols, technical reports, engineering calculations, change controls and other documentation as required.
• Maintain and present when required appropriate technical data to internal / external audit and inspection groups and Customers.
• Be a member of the cross-functional team responsible for ensuring that all Customer requirements are consistently being achieved and/or exceeded.
• Be flexible in supporting the production process and third party contractors to meet the business and facility needs.
• Report to Plant Manager or designated representative.

Requirements

• Ordinary Degree (Level 7) in Engineering or Technical Science.
• Previous experience in a medical manufacturing environment (ideally 3+years).
• Knowledge of ISO, FDA, GMP and six sigma requirements.
• PLC Programming desirable.
• Process Validation experience desirable.
• Professional interpersonal, self-presentation and communication skills.
• Demonstrate sound methodology in faultfinding techniques.
• Capability to take the lead in resolving technical issues.
• Understanding of Validation processes and regulated environments.
• Strong leadership skills with ability to motivate and direct.
• Positive team working approach and adherence to Policies and Procedures.
• Focus on Quality, Customer Satisfaction and continual improvement.