Computer System Validation Engineer

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.