Job Description Computer System Validation Labs (CSV)Engineer Horizon Controls Group are hiring for a Labs CSV Engineer to assist with our client's 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 Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
Experience 3–7 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.