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Process Validation Engineer

RM 3,500 - RM 5,200 / month

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ESSENTIAL JOB FUNCTION:

The Process Validation Engineer is responsible for facilitating process and software validation activities to ensure products and processes comply with relevant standards. The Process Validation Engineer is tasked with continuously improving processes and obtaining optimum product quality through CAPA methodologies. The engineer will work independently to determine appropriate actions to fulfill management objectives and support 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:

  • Perform process validation and capability.
  • Perform software validation and ensure QMS compliance.
  • Drive quality/manufacturing projects and initiatives utilizing DMAIC and/or Lean methodologies, APQP, and/or SPC to achieve and sustain improvements.
  • Perform MSAs.
  • Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.
  • Champion activities including containment, root cause analysis, corrective actions, and follow-up/verifications concerning customer complaints, ensuring complaints are closed within the target time frame.
  • Lead/facilitate or participate in risk analysis using FMEA, Fault Tree, or other suitable methods for existing and/or future processes and products.
  • Lead/facilitate or participate in root cause analysis for internal and external nonconformities using 5-why’s, fishbone, or other suitable methods, and challenge corrective actions through verification of effectiveness.
  • Lead/facilitate or participate in continuous improvement projects using Lean, DMAIC, Kaizen methodologies.
  • Physically walk processes, with/without team, to gain consensus for key areas for improvement.
  • Develop and administer training to personnel on quality functions, methodologies, and quality issues as required.
  • Create documentation, reports, presentations, and records consistent with internal and external requirements, complying with ISO, safety, environmental, and/or regulatory agencies.
  • Provide professional verbal and written communication to both external and internal parties, complying with company policies.
  • Champion projects/tasks/duties as defined by the Quality Head with metrics that track achievable goals.

Education:

  • Bachelor's degree in Industrial Engineering, Chemistry, or Material Science. Additional certifications in ASQ, SPC, Lean, or Six Sigma are a plus.

Experience:

  • 1-2 years in a Quality Assurance role. Experience with ISO 9001:2015, GMP, and automotive/medical products is a plus.

Skills:

  • Ability to work in a team concept.
  • Ability to resolve conflicts professionally.
  • Provide/maintain a “can-do” attitude with an emphasis on customer service.
  • Software proficiencies: Intermediate user level: Minitab, MS Office, email; Basic user level: Instrumentation programming.