Labs CSV Engineer

Computer System Validation Labs (CSV)Engineer

Horizon Controls Group are hiring for a Labs CSV Engineer to assist with our clients need within the pharma industry.

Position Summary

The Computer System Validation (CSV) Engineer is responsible for ensuring that computerized laboratory systems used in pharmaceutical operations are validated and maintained in a state of compliance with global regulatory requirements. This role supports GxP laboratory environments by planning executing and maintaining validation activities across laboratory instruments software and integrated systems to ensure data integrity patient safety and regulatory readiness.

Key Responsibilities

CSV & Compliance

• Lead and execute Computer System Validation (CSV) activities for laboratory systems in compliance with FDA EMA and global regulatory expectations.
  
• Ensure adherence to GxP regulations including 21 CFR Part 11 EU Annex 11 GAMP 5 and data integrity principles (ALCOA).
  
• Develop review and approve CSV documentation including Validation Plans User Requirements Specifications (URS) Risk Assessments IQ/OQ/PQ protocols Traceability Matrices and Validation Summary Reports.
  
• Maintain validated state through change control periodic reviews deviation management and revalidation activities.
  

Laboratory Systems & Equipment

• Support validation of laboratory computerized systems such as LIMS ELN CDS SDMS instrument control software and standalone analytical instruments.
  
• Collaborate with laboratory scientists quality IT and vendors to define system requirements and validation strategies.
  
• Participate in system implementations upgrades and decommissioning activities.
  

Quality & Inspection Readiness

• Support internal and external audits and regulatory inspections by providing CSV documentation and subject matter expertise.
  
• Perform impact assessments and risk-based validation approaches for system changes and deviations.
  
• Ensure validation documentation is inspection-ready and aligned with quality system procedures.
  

Cross-Functional Collaboration

• Work closely with Quality Assurance IT Automation and Laboratory Operations to align validation activities with business and compliance needs.
  
• Provide CSV guidance and training to laboratory and project teams as required.
  

Required Qualifications

Education

• Bachelors degree in Engineering Computer Science Life Sciences or a related technical discipline.
  

Experience

• 37 years of experience in Computer System Validation within a pharmaceutical biotechnology or regulated laboratory environment.
  
• Hands-on experience validating laboratory computerized systems (e.g. LIMS CDS ELN analytical instruments).
  
• Strong working knowledge of GxP regulations 21 CFR Part 11 Annex 11 and GAMP 5.
  

Technical Skills

• Experience with validation lifecycle methodologies and risk-based validation approaches.
  
• Familiarity with data integrity requirements and electronic records/electronic signatures.
  
• Ability to review vendor documentation and leverage supplier assessments.
  
• Proficiency with document management systems and change control processes.