QC CQV Scientist II: Instrument & System Validation

WuXi Biologics; Cranbury Township (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

WuXi Biologics seeks a Scientist II, QC CQV to oversee qualification, validation, maintenance, and lifecycle management of QC laboratory instruments, software, and systems. You will ensure GMP compliance, data integrity, and regulatory readiness while supporting efficient laboratory operations.

The role serves as a technical resource for equipment qualification, computerized system validation, software administration, and continuous improvement within Quality Control, enabling robust data

Qualifications

• Bachelor's degree with 4+ years in GMP/pharma QC environments.
• Master's degree with 2+ years in GMP/pharma QC environments.
• Experience with laboratory computerized systems, instrumentation, and validation preferred.

Responsibilities

• Coordinate calibration, PM, qualification for QC instruments.
• Lead IQ/OQ/PQ activities and document validation.
• Lead or support data integrity programs and audits.
• Manage Empower CDS, CDS/LIMS, and related software administration.

Skills

Verbal and written communication

Technical writing

GMP/GDP knowledge

Data integrity

Microsoft Excel/Office

Regulatory awareness (21 CFR 11, EU, G

Education

Bachelor's in Biology/Chemistry/Biochemistry/Pharmaceutical Sciences or related

Master's in related discipline

Tools

Empower CDS

SoftMax Pro

32 Karat

LabX

EndoScan-V

LIMS

Excel (validated)

Job description

WuXi Biologics seeks a Scientist II, QC CQV to oversee qualification, validation, maintenance, and lifecycle management of QC laboratory instruments, software, and systems. You will ensure GMP compliance, data integrity, and regulatory readiness while supporting efficient laboratory operations.

The role serves as a technical resource for equipment qualification, computerized system validation, software administration, and continuous improvement within Quality Control, enabling robust data