Validation Engineer II

Medline Industries, LP

Validation Engineer II providing technical support for sterile packaging projects at Medline. Ensuring compliance to regulations and optimizing validation processes across multiple modalities.

Posted 6/29/2026full-timeShanghai • 🇨🇳 ChinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in packaging validation processes, regulatory compliance, and quality assurance within the medical packaging industry. Proficient in managing multiple projects, providing technical support, and facilitating training for team members.

Highest-signal resume keywords

Packaging ValidationRegulatory ComplianceQuality System ExperienceISO13485 KnowledgeFDA Project Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Packaging Validation ProcessesMedical Device SterilizationQuality AuditingAnalytical SkillsProject Management

Soft Skills

Detail OrientedSelf-StarterEffective CommunicationTeam CollaborationConflict Management

Tools & Technologies

Packaging Related DatabaseSOP Compliance

Industry Keywords

Medical Packaging IndustryISO1348521CFR82021CFR210Continuous Improvement

About the role

Key responsibilities & impact

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
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

Requirements

What you’ll need

Bachelor’s degree or above with science or engineering background
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 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

Comp & perks

Health insurance
Life and disability insurance
401(k) contributions
Paid time off