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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