Validation Engineer

BEYONICS INTERNATIONAL PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company in the manufacturing sector is seeking a Process Engineer to oversee process validation, enhance productivity, and ensure product quality. The ideal candidate will have a Bachelor's in Engineering, along with 3-5 years of relevant experience. You will be responsible for training staff, resolving technical issues, and implementing improvement plans to enhance efficiency. Strong problem-solving skills and the ability to work collaboratively are essential for this role.

Qualifications

• 3-5 years of experience in a process engineering or validation role.
• Proficient in process validation methodologies and techniques.
• Familiarity with quality management systems and regulatory requirements.

Responsibilities

• Prepare and execute process validation protocols.
• Analyze defects and participate in Continuous Process Improvement programs.
• Ensure compliance with regulatory requirements for medical and automotive customers.

Skills

Problem-solving

Analytical skills

Teamwork

Education

Bachelor's degree in Process, Mechanical or Manufacturing Engineering

Job description

Primary Function

• Prepare and execute process validation protocols (MVP/IOPQ) and reports for new and existing product, process and equipment with tooling, production, maintenance and quality personnel for all customers before mass production.

• Train on MVP/IOPQ to all concerned department/personal and prepare training records.

• Work as a team with all departments to achieve mutual agreement on specification required by customers.

• Prepare instructions/procedures for the assembly processes, ECN/ECR/Deviation are drafted & executed.

• Execute engineering change notice (ECN)from customer/ in house and update ERP system promptly.

• Responsible for all engineering related activities of the assembly line concerned.

• Support assembly process and layout for each product inclusive update oracle routing

• Responsible for quality of products at all stages and drive production yield

• Identify and initiate actions to prevent occurrence and recurrence of product, process, quality systems nonconformities.

• Implement improvement plans to enhance efficiency of process, material and manpower.

• Responsible for resolving discrepancies and technical issues related to product with customers.

Duties and Responsibilities

• Analyze defect reported in-house and customer with quality, tooling and production.

• Attend to all daily quality and process related issues.

• Participate in the Continuous Process Improvement programme to improve productivity, reduce scrap, and perform internal quality system audit.

• Train and assess production staff on processes as well as WI as and when required.

• Attend routine production and quality meetings.

• Compliance to all regulatory and in house system requirements especially for medical and automotive customers

• Problem solving techniques - must be able to hands-on.

• To ensure all equipment on the mechanical assembly lines are in good functioning state.

• Equipment selection / reliable fixture designs for new projects and improvements and assist in other projects assign by the superior.

What we're looking for

• Bachelor's degree in engineering with a focus on Process, Mechanical or Manufacturing Engineering

• 3-5 years of experience in a process engineering or validation role, preferably in a manufacturing environment

• Proficient in process validation methodologies and techniques

• Strong problem-solving and analytical skills, with the ability to interpret and act on data

• Excellent communication and interpersonal skills, with the ability to work effectively in a team

• Familiarity with quality management systems and regulatory requirements in the manufacturing industry

• Proactive and detail-oriented, with a commitment to continuous improvement