Manufacturing Engineer: Process Optimization & Validation

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

Job summary

CREGG in Mayo, Ireland, is seeking a Manufacturing Engineer to support the design, development, validation, and continuous improvement of manufacturing processes within a regulated environment.

The role involves process development, validation (IQ/OQ/PQ), equipment qualification, and close collaboration with Quality, R&D, Regulatory Affairs, and Supply Chain teams to drive DFMs/DFAs and CAPA investigations.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering or related field.
• 2–7 years of manufacturing engineering experience in a regulated industry.
• 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 support audits/inspections.
• Specify, qualify, and maintain manufacturing equipment and tooling; collaborate with suppliers on equipment design.
• Work with Quality, R&D, Regulatory Affairs, Supply Chain and Operations teams; support DFMs and DFAs; assist CAPA investigations.
• Apply Lean, Six Sigma or other continuous improvement methodologies; drive cost reduction, waste elimination and efficiency improvements.

Skills

Process development

Cross-functional collaboration

LEAN/Six Sigma

CAPA investigations

Problem solving

Education

Bachelor’s degree in Manufacturing Engineering

Job description

CREGG in Mayo, Ireland, is seeking a Manufacturing Engineer to support the design, development, validation, and continuous improvement of manufacturing processes within a regulated environment.

The role involves process development, validation (IQ/OQ/PQ), equipment qualification, and close collaboration with Quality, R&D, Regulatory Affairs, and Supply Chain teams to drive DFMs/DFAs and CAPA investigations.