Validation Engineer II

Job Summary

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.

Job Responsibilities:

• Take role of packaging validation work to ensure quality and regulatory compliance; ensure meeting packaging project timeline.
• Work with supplier and stakeholders, manage conflicts, and communicate with internal team and cross-functional teams to push project development. Able to handle multiple projects with sense of urgency and prioritize per needs.
• Provides effective oversight to the 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.

Education level:
Bachelor’s degree or above with science or engineering background.

Work experience:

5 years’ work experience in medical packaging industry, or above 8 years’ work experience in manufacturing of medical device.

• Knowledge of medical device sterilization is highly preferred;
• Quality system and auditing experience is preferred.
• Knowledge of ISO
  13485, 21
  
  CFR
  820 or 21
  
  CFR
  210/211 is preferred.
• Strong analytical skills, detail oriented, self-starter, motivated and ability to work unsupervised.

Language:
Excellent verbal/written communication and presentation skills in both English and Mandarin.

Our benefit package includes 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 where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.