Senior Validation Process Engineer

3 days ago

Shah Alam, Selangor, Malaysia Porex Technologies Sdn Bhd (of Filtration Group) Full time 60,000 - 120,000 per year

ESSENTIAL JOB FUNCTION

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 include but are not limited to:

  • Ensuring that manufacturing processes, equipment, and systems consistently meet required specifications and regulatory standards.
  • Develop, implement, and execute validation protocols for equipment, processes, and systems. This includes 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. Knowledge of SPC programs such as Minitab should be an added advantage.
  • Develop, implement and execute Test Method Validation such as MSA, GR&R, etc. Knowledge of handling and programming laboratory equipment such as Optical measurement scope, Tensile and Compression Tester, Hardness Tester, Particle Size Analyzer, etc. should be added advantages.
  • 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) with Product Development Engineering and Production / Process Teams.
  • 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.
  • Software proficiencies: intermediate user level:  Minitab, MS Office, e-mail; basic user level: instrumentation programming.

  • Lead, Process Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Autowell (Malaysia) Sdn. Bhd. Full time 120,000 - 150,000 per year

    About the role We are seeking a talented and experienced Lead Process Engineer to join our team at Autowell (Malaysia) Sdn. Bhd. in Shah Alam, Selangor. In this full-time role, you will be responsible for leading the design, development and implementation of efficient and effective manufacturing processes to support our growing operations.What you'll be...

  • Electrical Process Engineer

    1 day ago

    Shah Alam, Selangor, Malaysia Autowell (Malaysia) Sdn. Bhd. Full time 40,000 - 80,000 per year

    About us Autowell (Malaysia) Sdn. Bhd. is a leading provider of high-quality electrical and electronic engineering solutions for the automotive industry. With over 20 years of experience, we are known for our innovative approaches, exceptional customer service, and commitment to excellence. Join our dynamic team and be a part of our continued growth and...

  • Process Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia ANCOM CROP CARE SDN BHD Full time 60,000 - 80,000 per year

    Responsibilities:-Research, design, and develop processes to optimize productivity and workflowCreate and develop new procedures and processesCollect data for analysis to uncover areas for improvements and innovationAnalyze, evaluate, and test new and existing processesOversee implementation of new processes and proceduresExamine existing processes and...

  • Senior Production Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia HPMT Industries Sdn Bhd Full time 120,000 - 240,000 per year

    Job Summary:We are seeking a highly skilled and experienced Senior Production Engineer to lead and optimize our manufacturing engineering activities. The ideal candidate will play a key role in driving continuous improvement, supporting new product introductions, and ensuring efficient, high-quality production operations in a precision cutting tools...

  • Senior Software Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Razer Full time 120,000 - 180,000 per year

    Joining Razer will place you on a global mission to revolutionize the way the world games. Razer is a place to do great work, offering you the opportunity to make an impact globally while working across a global team located across 5 continents. Razer is also a great place to work, providing you the unique, gamer-centric #LifeAtRazer experience that will put...

  • Process & Control Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Mycron Steel CRC Sdn Bhd Full time 60,000 - 80,000 per year

    The role We are seeking a talented Process & Control Engineer to join our team at Mycron Steel CRC Sdn Bhd in Shah Alam, Selangor. This is a full-time role that will play a key part in the continuous improvement and optimisation of our manufacturing processes.What you'll be doingAnalyze existing process, spot inefficiencies and makes recommendation for...

  • Senior Mechanical Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Trees Engineering - AI Talents Marketplace for the Energy Sector Full time 120,000 - 240,000 per year

    Duration:12-month contract (extendable depending on project requirements)Work Arrangement:Full-time, office-based at Engineering Contractor HQProject Type:Offshore Oil & Gas (Topsides / Brownfield / Greenfield)Key ResponsibilitiesPerform and review mechanical engineering design for offshore platforms (topsides, WHP, CPP)Develop and validate equipment...

  • Process and Project Engineers

    3 days ago

    Shah Alam, Selangor, Malaysia Purewater Engineering Sdn Bhd Full time 25,000 - 48,000 per year

    ResponsibilitiesTo design water and wastewater treatment projects and ensuring that they are meeting the budget, schedule and specifications.To have a good understanding on the project specifications and ensure that the project works are in compliance with the specifications and implemented with good engineering practice.To generate and submit the required...

  • Senior Software Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Codetrace Sdn Bhd Full time 120,000 - 240,000 per year

    About the role Codetrace Sdn Bhd, a leading software development company, is seeking a talented and experienced Senior Software Engineer to join our growing team in Shah Alam, Selangor or Penang. As a Senior Software Engineer, you will play a crucial role in designing, developing, and maintaining cutting-edge software solutions that drive our clients'...

  • Senior Software Engineer

    3 days ago

    Shah Alam, Selangor, Malaysia Razer Full time $60,000 - $120,000 per year

    Joining Razer will place you on a global mission to revolutionize the way the world games. Razer is a place to do great work, offering you the opportunity to make an impact globally while working across a global team located across 5 continents. Razer is also a great place to work, providing you the unique, gamer-centric #LifeAtRazer experience that will put...