HOYA LAMPHUN LTD.

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Nov 21, 2024

Process Validation Engineer

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Mueang Lamphun, Lamphun

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Job Descriptions

Responsibilities • Lead the 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.

Qualifications

Bachelor’s degree or above in Mechanical/Electrical/Industrial/ Chemical engineering or related fields.
At least 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.)
Excellent in English communication, Reading and Writing.
Highly motivated, organized and capable of managing priorities.
Proficient in MS Office, Minitab, Six sigma, Good technical writing skills.
Strong decision-making skills and a results-driven approach.

BenefitsSee all Benefits.

How to apply

- Click Apply Now via JobThai.com - Apply by Email - Send Application by Mail **** Out of an abundance of caution due to the concerns surrounding the current situation with the Coronavirus (COVID-19), we will be conducting our hiring process completely virtually. That means that all interviews and onboarding activities will be held online or over the phone. The health of our employees and candidates is our main priority and we hope you will forgive any inconvenience that may arise from this non-conventional approach. While the day-to-day approach has changed a bit during this time, our commitment to hiring the best talent in the industry and helping them to thrive both personally and professionally is stronger than ever. ******

Contacts

Khun Sakda Tiangtam

HOYA LAMPHUN LTD.

Tel. : 053-552-222,1904

Email : hoya_298@trustmail.jobthai.com (Email for job application & inquiry)

Fax : 053-552-217