Job Description:Our client is a MedicalDevice Manufacturing Industry.Position: Senior Validation EngineerWork Type: Monday Friday (5 Days/Week) Full-timeLocation: Lamphun, Thailand Travel Requirement: 10-20%Job Summary:We are seeking an experienced Senior Validation Engineer to lead and manage validation activities, ensuring compliance with regulatory standards and company goals. This role oversees validation testing, documentation, and process improvement efforts while coaching and guiding team members.Key Responsibilities:
Lead and manage validation teams to ensure timely and accurate completion of validation projects.
Develop, implement, and maintain validation systems in compliance with regulatory and internal standards (e.g., ISO13485, FDA, EU).
Provide technical leadership and coaching to ensure quality of validation work and continuous team development.
Ensure all validation activities support regulatory and compliance requirements.
Analyze and understand process control systems to support manufacturing improvements.
Resolve performance or process issues to ensure targets are met.
Collaborate with cross-functional teams including Quality, Engineering, and Production.
Perform additional tasks as assigned to support departmental success.
Qualifications:
Bachelors or Masters degree in Engineering, Science, or related field (e.g., Industrial Engineering, System Engineering, Chemical, Food Science, Pharmaceutical).
3-5 years of experience in Validation, process control, or manufacturing improvement.
Experience in the medical device industry with knowledge of regulatory requirements (ISO13485, FDA, EU MDR) is highly preferred.
Strong understanding of cleanroom and production environment standards.
Experience with Lean Manufacturing and continuous improvement initiatives.
Excellent problem-solving, analytical, and organizational skills.
Strong leadership, team collaboration, and interpersonal communication skills.
Proficient in validation tools/software such as Minitab and Microsoft Office.
Good written and spoken English communication and presentation skills.
Able to travel domestically up to 10-20%.
Required Skills:Team Collaboration Lean Manufacturing Compliance Collaboration Industrial Engineering Regulatory Requirements Organizational Skills Process Improvement Presentation Skills Validation Travel Communication Skills Continuous Improvement Coaching Manufacturing Documentation Software Testing Engineering Microsoft Office English Leadership Science Communication
