Senior Validation Engineer Medical Devices GMP Expert

Medline; Shanghai (VA); On-site; USD 110,000 - 160,000; Full time

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.

Skills

Validation expertise

QA documentation

English proficiency

Cross-functional teamwork

Analytical skills

Education

Bachelor degree or above in Biomedical/Chemical/Mechanical Eng or related

Tools

IQ/OQ/PQ protocols

Validation database tools

Job description

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.