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
1. Lead and execute Computer System Validation (CSV) activities for
laboratory systems in compliance with FDA, EMA, and global regulatory
expectations.
2. Ensure adherence to GxP regulations, including 21 CFR Part 11, EU
Annex 11, GAMP 5, and data integrity principles (ALCOA+).
3. 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.
4. Maintain validated state through change control, periodic reviews,
deviation management, and revalidation activities.
Laboratory
Systems & Equipment
5. Support validation of laboratory computerized systems such as LIMS,
ELN, CDS, SDMS, instrument control software, and standalone analytical
instruments.
6. Collaborate with laboratory scientists, quality, IT, and vendors to
define system requirements and validation strategies.
7. Participate in system implementations, upgrades, and
decommissioning activities.
Quality
& Inspection Readiness
8. Support internal and external audits and regulatory inspections by
providing CSV documentation and subject matter expertise.
9. Perform impact assessments and risk -based validation approaches for
system changes and deviations.
10. Ensure validation documentation is inspection -ready and aligned
with quality system procedures.
Cross -Functional
Collaboration
11. Work closely with Quality Assurance, IT, Automation, and Laboratory
Operations to align validation activities with business and compliance
needs.
12. Provide CSV guidance and training to laboratory and project teams
as required.
Required
Qualifications
Education
13. Bachelor's degree in Engineering, Computer Science, Life Sciences,
or a related technical discipline.
Experience
14. 3–7 years of experience in Computer System Validation within a
pharmaceutical, biotechnology, or regulated laboratory environment.
15. Hands -on experience validating laboratory computerized systems
(e.g., LIMS, CDS, ELN, analytical instruments).
16. Strong working knowledge of GxP regulations, 21 CFR Part 11, Annex
11, and GAMP 5.
Technical
Skills
17. Experience with validation lifecycle methodologies and risk -based
validation approaches.
18. Familiarity with data integrity requirements and electronic
records/electronic signatures.
19. Ability to review vendor documentation and leverage supplier
assessments.
20. Proficiency with document management systems and change control
processes.