Computer Systems Validation Engineer

Mix Talent; Cleveland (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biotechnology firm is seeking a Computer Systems Validation Engineer to ensure compliance of computerized systems with global regulatory standards. In this role, you will develop validation deliverables, support audits, and help enhance CSV processes while collaborating with various teams. The position demands a strong understanding of FDA regulations and GAMP guidelines, along with excellent communication and organizational skills.

Qualifications

• 3–5+ years of experience in Computer Systems Validation within biotechnology.
• Strong knowledge of FDA regulations and GAMP 5 principles.
• Experience validating GxP systems like LIMS, QMS, and ERP.

Responsibilities

• Develop and execute validation deliverables for GxP systems.
• Conduct risk assessments to determine validation strategies.
• Ensure robust documentation practices for inspections.

Skills

FDA regulations

GAMP 5

data integrity principles

validation of GxP systems

excellent communication skills

organizational skills

Education

Bachelor's degree in Life Sciences, Computer Science, Engineering

Job description

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JOB TITLE: Computer System Validation Engineer

Department: Validation

Reports to: Director of Validation

Description

POSITION OVERVIEW

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.
  
  

Job Identifier: #7978

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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