Senior Validation Process Engineer

Porex; Selangor; On-site; MYR 48,000 - 72,000; Full time

Job summary

A manufacturing company based in Malaysia, Selangor, is seeking a Quality Assurance professional. In this role, you will qualify and validate manufacturing processes, implement statistical process controls, and develop training and validation protocols. The ideal candidate will have a degree in a relevant scientific field and 2-4 years of experience in Quality Assurance, preferably in a regulated environment. Additional certifications such as Six Sigma are a plus. This role is vital for ensuring product quality and compliance with standards.

Qualifications

• 2 - 4 years of work experience in Process/Quality Assurance.
• Exposure to ISO 9001:2015 QMS, GMP, Automotive and Medical products is an advantage.

Responsibilities

• Ensure processes meet specifications and regulatory standards.
• Develop and implement validation protocols.
• Work with Product Development Engineering to launch new products.
• Implement Statistical Process Control for process improvement.
• Perform troubleshooting and root-cause analysis.
• Lead training and implementation of processes.
• Handle customer complaints and internal production rejects.
• Perform internal audits for quality management.

Skills

Ability to work in team concept

Ability to resolve conflicts professionally

Provide/maintain 'can-do' attitude with emphasis on customer service

Education

Degree in Industrial Engineering, Chemistry, or Material Science

Additional certifications such as ASQ, SPC, Lean, Six Sigma

Job description

The above employee is responsible to qualify and validate all manufacturing process (including test method, new machine installation and new production introduction) and implement process control based on PFMEA. He/ She shall be able to apply relevant QC/QA tools to determine process CTQ and control to assure products and processes are complying with relevant specification. The employee is responsible for continuously improving processes and obtaining optimum product quality by using CAPA methodologies. He/ She will work independently to determine appropriate actions to fulfill management objectives and is responsible for supporting the investigation of non-conformances by developing CAPA and using quality tools such as root cause analysis, statistical sampling, capability studies, problem solving, or any other statistical method.

Job Functions

• Ensuring manufacturing processes, equipment, and systems consistently meet required specifications and regulatory standards.
• Develop, implement, and execute validation protocols for equipment, processes, and systems, including ongoing verification during commercial production.
• Work closely with Product Development Engineering to launch new products by establishing Process FMEA, Quality Control Plan, Test Method, SOP and Work Instruction.
• Develop, implement and execute Statistical Process Control (SPC) to continuously improve the process control of new and existing products.
• Develop, implement and execute Test Method Validation such as MSA, GR&R, etc.
• Perform process troubleshooting and non-conformity root-cause analysis with skills such as 8D Problem Solving, DMAIC, 5Whys, Fish Bone Diagram, etc.
• Perform new machine, process and test method qualification such as Factory Acceptance Test with machine maker and Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
• Lead the training and implementation of new and existing processes to Quality, Production and relevant departments. Establish relevant SOP and WI.
• Handling customer complaints and internal production rejects.
• Perform Internal Audits to continuously improve the production process and Quality Management System. Support and attend external audits.
• Perform other tasks related to QMS and as required by Head of Department.

Job Requirements

Education

• Preferably with a Science educated background with a degree in Industrial Engineering, Chemistry or Material Science. Additional processional certifications such as ASQ, SPC, Lean, Six Sigma certifications is an added advantage.

Experience

• 2 - 4 years of work experience in Process/Quality Assurance role. Exposure to ISO 9001:2015 QMS, GMP, Automative and Medical products working environment is also an added advantage.

Skills

• Ability to work in team concept.
• Ability to resolve conflicts professionally.
• Provide/maintain “can-do” attitude with emphasis on customer service.