Senior Computer System Validation Lead (GxP)

Creative Solutions Services, LLC; Salt Lake (NM); On-site; USD 120,000 - 155,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computer systems in regulated environments.

The role requires expertise in validation lifecycles, 21 CFR Part 11/Annex 11, risk assessments, and cross-functional collaboration to ensure systems meet business and regulatory needs. Mentoring junior engineers and supporting audits are also part of the responsibilities.

Qualifications

• 8–12+ years of CSV experience in pharma/biotech/medical device industries.
• Experience validating enterprise systems such as LIMS, MES, and SAP.
• Strong knowledge of GxP regulations and CSV lifecycle requirements.
• Familiarity with 21 CFR Part 11, Annex 11, and related global standards.

Responsibilities

• Lead end-to-end CSV activities for GxP computerized systems.
• Develop and review Validation Plans, Protocols, Risk Assessments, and Traceability Matrices.
• Execute IQ/OQ/PQ activities and maintain validation documentation.
• Coordinate with IT, QA, Engineering, and Manufacturing teams.
• Support internal and regulatory audits and mentor junior CSV engineers.

Skills

Regulatory compliance

Risk assessment

Cross-functional collaboration

Education

Bachelor's or Master's degree

Tools

LIMS

MES

ERP SAP

Laboratory Systems

SCADA

PLC/HMI

QMS

DMS

Job description

Creative Solutions Services, LLC is seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computer systems in regulated environments.

The role requires expertise in validation lifecycles, 21 CFR Part 11/Annex 11, risk assessments, and cross-functional collaboration to ensure systems meet business and regulatory needs. Mentoring junior engineers and supporting audits are also part of the responsibilities.