QA Validation Engineer — Pharma Compliance Leader

AmbioPharm - A Global Peptide CDMO; North Augusta (SC); On-site; USD 90,000 - 125,000; Full time

Job summary

AmbioPharm - A Global Peptide CDMO in the United States is seeking a QA Validation Engineer for onsite work in North Augusta, SC. The role focuses on independent QA oversight of qualification and validation activities to ensure GMP compliance and data integrity across manufacturing processes, equipment, utilities, and analytical methods.

The ideal candidate will review and approve VMPs, URS, DQ/IQ/OQ/PQ packages, and validation reports while supporting audits, CAPAs, and change controls.

Qualifications

• Bachelor’s degree in a scientific discipline relevant to QA/validation in pharma.
• Minimum 5 years in QA, validation, or manufacturing within regulated industry.
• Strong knowledge of cGMP, FDA/ICH/USP guidelines and data integrity principles.
• Experience reviewing qualification, validation, and lifecycle documentation.
• Experience with process, equipment, cleaning validation, and analytical method validation.

Responsibilities

• Provide QA oversight and approval of validation documentation across lifecycle.
• Review equipment, utility qualification, and process validation protocols and reports.
• Assess deviations, CAPAs, and change controls related to validation activities.
• Ensure compliance with FDA, ICH, USP, EU GMP, and regulatory requirements.
• Collaborate with Manufacturing, Engineering, QC, and Technical Services to resolve issues.
• Support internal and customer/regulatory inspections and audits.

Skills

Quality Assurance

Validation

Regulatory Knowledge

Documentation

Communication

Cross-functional Collaboration

Education

Bachelor's degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related

Tools

Empower

CSV

Microsoft Office

Job description

AmbioPharm - A Global Peptide CDMO in the United States is seeking a QA Validation Engineer for onsite work in North Augusta, SC. The role focuses on independent QA oversight of qualification and validation activities to ensure GMP compliance and data integrity across manufacturing processes, equipment, utilities, and analytical methods.

The ideal candidate will review and approve VMPs, URS, DQ/IQ/OQ/PQ packages, and validation reports while supporting audits, CAPAs, and change controls.