Validation Engineer II

Medline; Virginia (MN); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) contributions

Paid time off

Résumé du poste

Medline is looking for a professional to provide technical support for sterile packaging projects across various product divisions to maintain regulatory compliance. Responsibilities include overseeing validation processes, communicating with suppliers and stakeholders, and providing technical training for junior members.

The role requires strong analytical skills, a bachelor’s degree in science or engineering, and at least 5 years of experience in the medical packaging industry. Benefits include health insurance and 401(k) contributions.

Qualifications

• 5 years of experience in medical packaging industry or 8 years in medical device manufacturing.
• Knowledge of medical device sterilization preferred.
• Experience with quality systems and auditing.

Responsabilités

• Ensure quality and regulatory compliance in packaging validation.
• Manage conflicts and communicate effectively with teams.
• Provide oversight to validation projects ensuring timely completion.
• Support FDA/Mock FDA projects and packaging validation evaluation.

Connaissances

Analytical skills

Attention to detail

Technical training abilities

Ability to manage multiple projects

Formation

Bachelor's degree or above in science or engineering

Description du poste

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 Description

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.

Qualifications

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.

Preferred Knowledge/experience

• 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.

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

Benefits

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.

Equal Opportunity Statement

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.