Validation Engineer II (Medical Packaging)

Location: Shanghai, China

Company

hirify.global develops and supplies medical products and supports sterile packaging and regulatory compliance across its product divisions.

What you will do

• Lead sterile packaging validation activities to support product quality, regulatory compliance, and project timelines.
• Coordinate with suppliers, stakeholders, and cross-functional teams to advance multiple packaging projects and resolve conflicts.
• Oversee validation development, quality issue resolution, corrective and preventive actions, and project deliverables.
• Maintain and improve procedures, review packaging databases, and identify opportunities to optimize validation processes.
• Support FDA and mock FDA projects, including packaging validation evaluations and supplier improvements.
• Provide technical training, knowledge sharing, and onboarding support for junior team members.

Requirements

• Bachelor’s degree or above in science or engineering.
• At least five years of experience in the medical packaging industry, or more than eight years of experience in medical device manufacturing.
• Excellent verbal and written communication and presentation skills in both English and Mandarin.
• Strong analytical skills, attention to detail, self-motivation, and the ability to work independently.
• Ability to manage multiple projects, prioritize urgent needs, and work with suppliers and cross-functional stakeholders.

Nice to have

• Knowledge of medical device sterilization.
• Experience with quality systems and auditing.
• Knowledge of ISO 13485, 21 CFR 820, or 21 CFR 210/211.

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working an average of 30 or more hours per week.
• Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Focus on inclusion, belonging, career growth, and providing resources for effective work.