Validation Engineer II

About the Role

Provide technical support for sterile packaging related projects among various Medline product divisions to maintain compliance to regulation and industry standards. Apply engineering principles to develop, support and troubleshoot packaging validation processes and challenges across multiple modalities.

Responsibilities

• Take ownership of packaging validation work to ensure quality and regulatory compliance; ensure meeting packaging project timelines.
• Work with suppliers and stakeholders, manage conflicts, and communicate with internal and cross-functional teams to drive project development.
• Handle multiple projects with a sense of urgency and prioritize based on needs.
• Provide effective oversight to validation development projects and quality issue handling, ensuring timely completion of project deliverables, implementation of corrective actions, and preventative actions.
• Ensure personal work compliance with SOPs, maintain regulatory compliance, initiate and update procedures to eliminate gaps with regulation requirements, and find improvement opportunities to optimize packaging validation processes.
• Provide technical training for junior team members, support team knowledge sharing and training activities including new hire training.
• Identify opportunities for continuous improvement during audits/vigilance of suppliers, prioritize defects found, and supervise corrective actions to ensure suppliers maintain regulatory compliance.
• Support FDA/Mock FDA projects, responsible for packaging validation evaluation and supplier improvement.
• Review and update packaging-related databases.
• Perform other work assigned by line manager.

Requirements

• Bachelor’s degree or above with a science or engineering background.
• 5 years’ work experience in the medical packaging industry, or above 8 years’ work experience in manufacturing of medical devices.

Preferred Qualifications

• Knowledge of medical device sterilization is highly preferred.
• Quality system and auditing experience is preferred.
• Knowledge of ISO13485, 21CFR820, or 21CFR210/211 is preferred.
• Strong analytical skills, detail-oriented, self-starter, motivated, and ability to work unsupervised.
• Excellent verbal/written communication and presentation skills in both English and Mandarin.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• For employees working less than 30 hours per week: 401(k) contributions, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.