Process Validation Engineer

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The Process Validation Engineer is responsible for leading new process improvement initiatives from concept to production release, ensuring timely and budget-compliant execution while collaborating with various teams to enhance product quality and efficiency.

Kewajiban

• New Process Improvement (NPI) initiatives from initial concept through to production release, ensuring all milestones are met on time and within budget.
• Coordinate with design engineering to review product designs for manufacturability and identify opportunities for cost reduction and process improvements.
• Develop and maintain NPI schedules, ensuring alignment with overall project timelines and business objectives.
• Collaborate with manufacturing teams to establish production processes, including equipment selection, tooling design, and assembly procedures.
• Conduct feasibility studies and risk assessments to anticipate and mitigate potential challenges.
• Implement quality control measures and performance metrics to monitor and optimize product quality.
• Act as a liaison between engineering, manufacturing and supply chain teams to resolve technical issues and ensure smooth production flow.
• Provide regular updates and reports to senior management on NPI progress, including status updates, key metrics, and risk assessments.
• Conduct equipment, process, and software validation.
• Issue Validation/Qualification protocols (IQ/OQ/PQ), coordinate the execution and ensure that all activities are executed according to the approved protocol.
• Document any deviation from the approved protocols (IQ/OQ/PQ).
• Consolidate all test data and ensure all requirements are completed prior to post-execution approval.
• Issue qualification reports (IQ/OQ/PQ).
• Develop or design machine jigs and tools to increase productivity and quality.

Kualifikasi

• Bachelor’s degree or above in Mechanical/Electrical/Industrial/Chemical engineering or related fields.
• 1-3 years of experience in process validation within a regulated industry (Medical Devices, Pharmaceutical).
• Understanding of quality standards and health & safety regulations (ISO13485, MDR, MDSAP etc.).
• Highly motivated, organized and capable of managing priorities.
• Excellent in English communication, Reading and Writing.
• Proficient in MS Office, Minitab, Six sigma, Good technical writing skills.
• Strong decision-making skills and a results-driven approach.