
Validation Engineer
2 weeks ago
As a Validation Engineer, you will ensure that the manufacturing processes and products meet internal and external quality standards. Your role will involve developing and implementing validation protocols, analyzing data, and collaborating with cross-functional teams to maintain compliance and drive continuous improvement.
Key Responsibilities- 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.
- Analyze defect reported in-house and customer with quality, tooling and production.
- Participate in the Continuous Process Improvement programme to improve productivity, reduce scrap, and perform internal quality system audit.
- Compliance to all regulatory and in house system requirements especially for medical and automotive customers
- 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, preferable 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.
The Talent People 24C2589
Tell employers what skills you have
Manufacturing Engineering
Quality System
Continuous Process Improvement
Quality Management Systems
Manufacturing Processes
GMP
Process Validation
Routing
Audit Compliance
Process Engineering
Assembly Processes
Regulatory Requirements
Manufacturing
Layout
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