Senior Computer System Validation Lead (GxP)

Katalyst-Healthcares-; 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

Job Description:
We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

Responsibilities:

• Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
• Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Execute and oversee IQ, OQ, and PQ activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
• Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Perform risk assessments using GAMP 5 methodology.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning projects.
• Coordinate validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor junior CSV engineers and provide technical guidance.
• Maintain validation lifecycle documentation according to company SOPs.

Requirements:

• Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
• 8–12+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Strong understanding of GxP regulations and computerized system validation.
• Experience validating enterprise systems such as:
  • LIMS.
  • MES.
  • ERP (SAP).
  • Laboratory Systems.
  • SCADA.
  • PLC/HMI.
  • Manufacturing Execution Systems.
  • Electronic Batch Records (EBR).
  • Quality Management Systems (QMS).
  • Document Management Systems (DMS).