TEST-IND - (Senior) Test Industrialization Engineer (Equipment Validation)

SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

【Job Overview】

The Test Industrialization Engineer (Equipment Validation) is responsible for ensuring the reliability and accuracy of (test) equipment used in the development of medical devices and/or testing during manufacturing of medical devices. This role involves defining validation strategies globally, executing validation activities, and maintaining equipment documentation to support compliance with regulatory requirements.

【Responsibilities】

• Validation Strategy Development: Develop and implement comprehensive validation strategies together with user departments for new and existing (test) equipment, such as environmental chambers, drop tester, tensile tester, and manual/automated testing equipment.
• Validation Execution: Conduct factory/site acceptance tests (FAT/SAT) and IQ/OQ/PQ validation activities for (test) equipment, ensuring that the equipment meets specified performance criteria and is suitable for its intended use.
• Documentation Management: Create and maintain standardized templates for equipment validation documentation, such as User Requirement Specifications, IQ/OQ/PQ protocols and reports, and Work Instructions.
• Collaboration: Work globally with cross-functional teams, including test/ industrialization engineers, validation control, quality assurance/control, to ensure validation activities comply with relevant regulatory requirements and company standards.
• Failure Investigation: Assist in failure investigations and root cause analyses occurred during equipment qualification.
• Continuous Improvement: Identify opportunities for improvement and implement changes to enhance the efficiency and effectiveness of the equipment validation process.

【Qualifications】

• Bachelor’s degree in Engineering (e.g., Mechanical, Biomedical, Electrical) or a related field.
• 3+ years experience in equipment validation field
• Strong written and verbal communication skills (Mandarin and English).
• Excellent problem-solving, analytical, and organizational skills.
• Skilled in the use of Microsoft Office Suite.
• Experience in generating and executing IQ/OQ/PQ documentation for GMP equipment is a plus.
• Experience in electronic products/equipment according to IEC 60601 or similar standards is a plus.
• Strong understanding of validation principles, regulatory requirements, and quality systems. Knowledge of GMP, ISO, ASTM and FDA rules and regulatory requirements (etc. ISO 13485, ISO 14971, ISO 11608, ASTM D4169, 21 CFR Part 11, 21 CFR 820 and FDA GMPs) is a plus.