Job Description
Job Description
JOB TITLE: Computer System Validation Engineer
Department: Validation
Reports to: Director of Validation
As a Computer System Validation (CSV) Engineer in a biotechnology environment, you will
play a critical role in ensuring that computerized systems used in GxP-regulated activities (e.g.,
clinical, laboratory, manufacturing, quality) are validated and maintained in compliance with
FDA, EMA, and other global regulatory standards. This role involves close collaboration with
cross-functional teams to implement, validate, and sustain systems that support key biotech
processes from R&D through commercial production.
Essential Duties and Responsibilities
· Develop and execute validation deliverables for new and existing GxP systems in
alignment with regulatory guidelines (21 CFR Part 11, EU Annex 11, GAMP 5).
· Partner with system owners, QA, IT, and vendors to define User Requirements
Specifications (URS), and ensure traceability through Functional and Design
Specifications, Test Plans, and Summary Reports.
· Lead CSV efforts for systems supporting biotech processes such as:
· Laboratory systems (e.g., LIMS, ELN)
· Clinical trial management systems (e.g., CTMS, EDC)
· Quality systems (e.g., QMS, Document Management Systems)
· Manufacturing systems (e.g., MES, SCADA)
· Conduct risk assessments and impact analyses to determine appropriate validation
strategies.
· Ensure robust documentation practices that meet internal SOPs and inspection-
readiness standards.
· Support change control processes, periodic reviews, revalidation efforts, and data
integrity compliance.
· Provide support during internal audits and external regulatory inspections.
· Contribute to continuous improvement of CSV processes and templates.
Qualifications
· Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field.
· 3–5+ years of experience in CSV within the biotechnology or pharmaceutical industry.
· Strong working knowledge of FDA regulations, GAMP 5, and data integrity principles.
· Experience validating GxP systems such as LIMS, QMS, ERP, or laboratory equipment
with software components.
· Familiarity with cloud-based systems (e.g., SaaS platforms) and their validation
challenges.
· Excellent written and verbal communication skills.
· Highly organized and able to manage multiple priorities in a fast-paced biotech
environment.
Physical Demands
· Primarily a desk-based role with prolonged periods of computer use.
· Occasional work in laboratory, cleanroom, or manufacturing environments may be
required.
· Ability to occasionally lift and carry items up to 25lbs (e.g., laptops, documentation
binders, or small equipment).
· May require wearing appropriate personal protective equipment (PPE) when entering
GMP or lab areas.
· Occasional walking, standing, or climbing stairs within office or facility settings.
· Must be able to travel between company sites or to vendor locations, if needed.
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