Senior Validation Engineer
Senior Validation Engineer
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Job Description
Our client is a MedicalDevice Manufacturing Industry.
Position: Senior Validation Engineer
Work Type: Monday Friday (5 Days/Week) Full-time
Location: 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%.
Employment Type
Full Time
