Pharma QA Validation Engineer – Onsite (Relocation)

Corden Pharma - A Full-Service CDMO; North Augusta (SC); On-site; USD 110,000 - 160,000; Full time

Job summary

Corden Pharma - A Full-Service CDMO in North Augusta, SC is seeking a Quality Assurance Validation Engineer to provide independent QA oversight of qualification and validation activities across manufacturing, equipment, utilities, cleaning processes, and analytical methods.

The role collaborates with manufacturing, engineering, validation, facilities, QC and technical services to ensure compliant, data‑driven validation programs and inspection readiness throughout the lifecycle.

Qualifications

• Bachelor-level degree in a scientific discipline plus 5+ years in QA/Validation within regulated life sciences.
• Strong knowledge of FDA cGMPs, 21 CFR Parts 210/211, USP and ICH guidelines.
• Experience reviewing qualification, validation and lifecycle documentation.
• Experience with process, equipment and cleaning validation; strong data evaluation skills.
• Understanding risk management and validation lifecycle concepts.

Responsibilities

• Provide QA oversight and approval of validation lifecycle docs (VMPs, protocols, reports).
• Review and approve equipment, utilities, process, and cleaning validation activities.
• Assess data packages, ensuring acceptance criteria are justified and supported.
• Support audits, inspections, and regulatory readiness for validation programs.
• Collaborate with cross-functional teams to resolve validation-related issues.
• Assist in developing and updating SOPs for validation and quality systems.

Skills

Quality Assurance

Validation

cGMP

Regulatory compliance

Process validation

Equipment qualification

Analytical method validation

Data integrity

Documentation

Risk management

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Bachelor's degree in Engineering

Bachelor's degree in Pharmaceutical Sciences

Tools

Empower software

CSV familiarity

Job description

Corden Pharma - A Full-Service CDMO in North Augusta, SC is seeking a Quality Assurance Validation Engineer to provide independent QA oversight of qualification and validation activities across manufacturing, equipment, utilities, cleaning processes, and analytical methods.

The role collaborates with manufacturing, engineering, validation, facilities, QC and technical services to ensure compliant, data‑driven validation programs and inspection readiness throughout the lifecycle.