Validation Engineer II

Job title: Validation Engineer II

About the Role Provide technical support for sterile packaging-related projects across Medline product divisions to maintain regulatory compliance and meet standards. Apply engineering principles to develop, support, and troubleshoot packaging validation processes across multiple modalities and ensure timely project delivery.

What You'll Do

• Take lead on packaging validation work to ensure quality and regulatory compliance; ensure meeting packaging project timeline.
• Work with suppliers and stakeholders, manage conflicts, and communicate with internal and cross-functional teams to push project development.
• Able to handle multiple projects with sense of urgency and prioritize per 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 SOPs, maintain regulatory compliance.
• Initiate and update procedures to eliminate gaps with regulation requirements, and find improvement opportunities to optimize packaging validation process.
• Provide technical training for junior team members, support on team knowledge sharing and training activities including new hire training.
• Identify opportunity for continuous improvement during audit/vigilance to supplier, prioritizing defect found in audit/ vigilance, supervise the corrective and ensure supplier is able to maintain regulatory compliance.
• Support on FDA/Mock FDA project, responsible for packaging validation evaluation and supplier’s improvement.
• Packaging related database review and update.
• Other work assigned by line manager.

What We're Looking For

• Education: Bachelor’s degree or above with science or engineering background.
• Experience: 5 years’ work experience in the medical packaging industry, or 8+ years in manufacturing of medical devices.
• Preferred knowledge/experience: Knowledge of medical device sterilization is highly preferred; quality system and auditing experience is preferred.
• Knowledge of ISO13485, 21 CFR 820 or 21 CFR 210/211 is preferred.
• Skills: Strong analytical skills, detail oriented, self-starter, motivated and able to work unsupervised.
• Language: Excellent verbal/written communication and presentation skills in English and Mandarin.

Nice to Have

• Knowledge of medical device sterilization is highly preferred.
• Quality system and auditing experience is preferred.

Compensation & Benefits

• Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles with less than 30 hours per week, benefits include 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.