Process Engineer

CREGG; Connacht; On-site; Confidential; Full time

Job summary

CREGG is hiring a Process Project Engineer to support a Global regulated manufacturing operation in Co. Mayo. The role involves designing, developing, validating, and continuously improving manufacturing processes.

You will create SOPs, process flow diagrams, and work instructions while driving efficiency and quality improvements. Key activities include leading IQ/OQ/PQ validations, installing and validating new automation equipment, supporting audits, and collaborating with Quality, R&D,

Qualifications

• Bachelor degree required in a relevant engineering field.
• Experience in a regulated manufacturing environment preferred.
• Hands-on experience with process validation and documentation.

Responsibilities

• Design, develop, and improve manufacturing processes.
• Create process flow diagrams, SOPs, and work instructions.
• Lead process validation activities (IQ/OQ/PQ) and validation of new automation equipment.
• Support audits and maintain quality system documentation.
• Collaborate with Quality, R&D, Regulatory, Supply Chain and Operations.

Skills

Process development

Process optimization

Lean Six Sigma

Education

Bachelor’s degree in Manufacturing/Mechanical/Biomedical/Industrial Engineering or related field

Job description

Process Project Engineer

CREGG are hiring for a Process Project Engineer to work with a Global regulated Manufacturing company in Co. Mayo

For more information contact Mark: 086 1901346 or [e-mail]

Job Summary

The Process Project Engineer will support project in the design, development, validation, and continuous improvement of manufacturing processes .

Key Responsibilities

Process Development & Optimization

• Design, develop, and improve manufacturing processes
• Create process flow diagrams, work instructions, and standard operating procedures (SOPs)
• Optimize processes for quality, yield, cost, and cycle time
• Support transfer of products from R&D to manufacturing

Validation & Compliance

• Lead and execute process validation activities (IQ/OQ/PQ)
• Lead the installation, commissioning and validation of new automation equipment onto site
• Support audits and inspections (FDA, notified bodies, internal audits)
• Maintain manufacturing documentation in accordance with quality system requirements

Equipment & Tooling

• Specify, qualify, and maintain manufacturing equipment and tooling
• Collaborate with suppliers on equipment design and installation
• Troubleshoot equipment and process issues to minimize downtime

Cross-Functional Collaboration

• Work closely with Quality, R&D, Regulatory Affairs, Supply Chain, and Operations teams
• Support design for manufacturability (DFM) and design for assembly (DFA) efforts
• Assist in root cause investigations and corrective actions (CAPA)

Continuous Improvement

• Apply Lean, Six Sigma, or other continuous improvement methodologies
• Drive cost reduction, waste elimination, and efficiency improvements
• Analyze process data and implement corrective and preventive actions

Required Qualifications

Education

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field

Experience

• 2–7 years of manufacturing engineering experience (level dependent)
• Experience in a regulated industry
• Hands-on experience with process validation and documentation