Manufacturing Validation Engineer - Lean & Compliance

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a manufacturing process engineer to optimize processes using Six Sigma and LEAN methods, and to redesign equipment as needed.

The role focuses on qualification tests, CAPA and compliance, and developing work instructions for production. You will also manage project plans and mentor technicians.

Candidates should have a bachelor's in engineering or science, plus strong analytical, writing and communication skills, with CAD and MS Project experience.

Qualifications

• Bachelor's Degree in Engineering or Science with at least 2 years’ experience.
• Strong analytical thinking and clear articulation.
• Proficient in technical writing with clarity and structure.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Good communication and stakeholder management skills.
• Familiar with MS Office including MS Project; CAD experience.
• Basic understanding of statistical techniques.
• Knowledge of FDA regulations for medical device industry.

Responsibilities

• Optimize manufacturing processes using Six Sigma and LEAN methods for continuous improvement and redesign of equipment.
• Develop experiments and tests to qualify and validate manufacturing processes; analyze results and prepare reports.
• Analyze and resolve manufacturing and compliance issues (CAPA, non-conformances, audit observations).
• Develop training and documentation materials for production to enable knowledge transfer of project and manufacturing processes.
• Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools.
• Oversee manufacturing support tasks; train technicians and coordinate technician work.
• Other incidental duties assigned by Leadership.

Skills

Six Sigma

LEAN methodologies

Analytical thinking

Technical writing

Communication

Project management

Education

Bachelor's degree in engineering or science

Tools

MS Office

MS Project

CAD

Job description

Recruit Express Pte Ltd is seeking a manufacturing process engineer to optimize processes using Six Sigma and LEAN methods, and to redesign equipment as needed.

The role focuses on qualification tests, CAPA and compliance, and developing work instructions for production. You will also manage project plans and mentor technicians.

Candidates should have a bachelor's in engineering or science, plus strong analytical, writing and communication skills, with CAD and MS Project experience.