QA Validation Engineer – On-Site, cGMP Compliance

AmbioPharm, Inc.; North Augusta (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

AmbioPharm, Inc. in North Augusta, SC is seeking a QA Validation Engineer to provide independent QA oversight of qualification and validation activities across manufacturing, utilities, equipment, and analytical methods.

The role ensures cGMP compliance, data integrity, and readiness for inspections. The candidate will collaborate with Manufacturing, Engineering, Validation, Facilities, Metrology, Quality Control, and Technical Services to maintain lifecycle validation and drive continuous

Qualifications

• Strong knowledge of cGMP regulations (FDA, ICH, USP) and data integrity practices.
• Proficient in reviewing qualification, validation, and lifecycle documentation.
• Experience with process validation, equipment qualification, cleaning validation, and analytical method validation.
• Excellent technical writing, documentation review, and data evaluation skills.
• Ability to work cross-functionally with Manufacturing, Validation, Quality Control, and Technical Services.

Responsibilities

• Review and approve validation lifecycle documentation (VMPs, protocols, reports, periodic reviews).
• Review and approve equipment qualification packages (URS, DQ, IQ, OQ, PQ).
• Oversee utility qualification activities (water systems, HVAC, GMP utilities).
• Validate process validation protocols and reports for commercial API manufacturing.
• Review cleaning verification/validation protocols and related risk assessments.
• Ensure compliance with FDA, ICH, USP, EU GMP requirements.

Skills

cGMP knowledge

Documentation review

Cross-functional collaboration

Risk assessment

Education

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

Tools

Empower software

Job description

AmbioPharm, Inc. in North Augusta, SC is seeking a QA Validation Engineer to provide independent QA oversight of qualification and validation activities across manufacturing, utilities, equipment, and analytical methods.

The role ensures cGMP compliance, data integrity, and readiness for inspections. The candidate will collaborate with Manufacturing, Engineering, Validation, Facilities, Metrology, Quality Control, and Technical Services to maintain lifecycle validation and drive continuous