Senior GxP Computer System Validation Engineer

ADP, Inc.

Kentucky

Hybrid

USD 110,000 - 140,000

Full time

3 days ago

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Job summary

US WorldMeds is seeking a Computer System Quality Validation Engineer to ensure compliant, efficient validation of computerized systems across GMP processes. You will oversee SDLC deliverables, manage validation activities, and drive data integrity and audit-trail improvements.

The role requires a Bachelor's degree and 5+ years of QA/validation experience in biotech/pharma, with strong knowledge of cGMP, GAMP, ICH guidelines, and cross-functional collaboration.

Qualifications

Bachelor’s degree in science or related field.
Minimum 5 years QA/Validation experience in biotech/pharma.
Understanding of cGMPs and regulatory guidance (GAMP, ICH, USP).
Leading or managing projects is beneficial.
Strong communication and cross-functional collaboration.

Responsibilities

Provide QA oversight for SDLC deliverables supporting GxP operations.
Lead validation teams and promote validation best practices.
Review validation records to ensure regulatory conformance.
Collaborate on data integrity, audit trails, and access controls.
Ensure documentation is archived for inspections.

Skills

Quality Assurance

CSV/QA validation

Regulatory knowledge

GxP compliance

Cross-functional collaboration

Documentation & reporting

Leadership / project management

Education

Bachelor’s Degree in Science or related technical field

Tools

Veeva

StarLIMS

Kaye/TempTale

Document Control Software

Calibration manager databases

Electronic Lab Notebooks

Job description

The role requires a Bachelor's degree and 5+ years of QA/validation experience in biotech/pharma, with strong knowledge of cGMP, GAMP, ICH guidelines, and cross-functional collaboration.

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