Senior Validation Engineer Medical Devices GMP Expert

Medline

Shanghai (VA)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline seeks a senior Validation expert to act as site SME for validation across equipment, sterile packaging, water systems and injection molding processes. You will define CPPs/CQAs, draft IQ/OQ/PQ protocols and validation reports, and oversee on-site validation with data integrity and traceability.

Expect extensive collaboration with engineering, production and R&D to ensure regulatory compliance.

Qualifications

Bachelor’s degree or higher in a relevant engineering/quality field.
Minimum 7+ years of validation experience in medical device industry.
Familiar with ISO 13485, regulatory requirements (FDA 21 CFR 820, EU MDR).
Proficient in writing and reviewing IQ/OQ/PQ protocols and validation reports.

Responsibilities

Act as site SME for validation of equipment, sterile packaging, and processes.
Define CPPs and CQAs for complex manufacturing processes using risk-based approaches.
Draft, review, approve IQ, OQ, PQ protocols and validation reports.
Lead on-site validation execution and verify data integrity and traceability.
Draft and optimize validation SOPs, master plans, and validation database.
Manage validation deviations, non-conformances and change controls; drive CAPAs.
Support audits and regulatory inspections with complete validation documentation.
Coordinate with engineering, production, R&D and cross-functional teams on validation matters.
Ensure validation activities comply with ISO 13485, FDA QSR 21 CFR 820, MDR and local GMP requirements.