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Computer System Validation Director Jobs (NOW HIRING)

Compli

CSV Lead/ Computer System Validation Lead

Marietta, PA · On-site

$96K - $127K/yr

CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.

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Computer System Validation Director information

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How much do computer system validation director jobs pay per hour?

As of Jun 23, 2026, the average hourly pay for computer system validation director in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

What are the main challenges a Computer System Validation Director might face when leading validation projects across multiple global sites?

A Computer System Validation Director often encounters challenges such as navigating differing regulatory requirements across countries, coordinating cross-functional teams in various time zones, and ensuring consistent validation standards are maintained globally. Balancing project timelines with compliance demands can be difficult, especially when local teams have varying levels of validation experience. Strong communication, project management skills, and a deep understanding of international regulations are essential for overcoming these obstacles and ensuring successful, compliant system implementations.

What is the salary of a CSV engineer?

A Computer System Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Senior CSV engineers with specialized skills or certifications can earn higher salaries, especially in regulated sectors like pharmaceuticals and biotech where validation expertise is critical.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as 21 CFR Part 11. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or IQ/OQ/PQ. The field provides stable employment with growth potential, especially for those with technical expertise and attention to detail.

What are the key skills and qualifications needed to thrive as a Computer System Validation Director, and why are they important?

To thrive as a Computer System Validation Director, you need expertise in computer system validation (CSV), regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or IT. Familiarity with validation lifecycle management tools, quality management systems (QMS), and knowledge of industry standards like GAMP 5 are typically required. Strong leadership, project management, and communication skills are essential for leading cross-functional teams and ensuring clarity in compliance objectives. These skills are crucial to ensure validated systems meet regulatory requirements, minimize risk, and support organizational quality goals.

What is the salary of computer system validation?

The salary for a Computer System Validation (CSV) Director typically ranges from $120,000 to $180,000 annually, depending on experience, location, and industry. Additional compensation may include bonuses and benefits, and the role often requires knowledge of regulatory standards like GxP and validation tools.

What is the difference between Computer System Validation Director vs Validation Manager?

AspectComputer System Validation DirectorValidation Manager
CredentialsTypically requires a Bachelor's or Master’s in Life Sciences, Engineering, or related fields; certifications like GxP, CSV certificationsSimilar credentials, often with additional certifications in validation or quality assurance
Work EnvironmentLeads validation teams in pharmaceutical, biotech, or medical device companies; strategic roleManages validation activities, oversees teams, and ensures compliance at operational levels
Industry UsageUsed across regulated industries for high-level validation oversightCommonly used in the same industries for day-to-day validation management

The main difference is that the Computer System Validation Director holds a strategic, leadership role overseeing validation programs, while the Validation Manager handles daily validation activities and team management. Both roles require similar credentials and are vital in regulated industries like pharma and biotech.

What are Computer System Validation Directors?

Computer System Validation Directors oversee and manage the validation of computer systems within regulated industries, such as pharmaceuticals, biotechnology, or medical devices. Their primary responsibility is to ensure that all computer systems used for business and regulatory purposes comply with industry standards and regulatory requirements, such as FDA or EMA guidelines. They often lead validation teams, develop validation strategies and protocols, and work closely with IT, quality assurance, and compliance departments. This role is crucial to ensure data integrity, patient safety, and regulatory compliance throughout the system lifecycle.

Is CSV a skill?

In the context of a Computer System Validation Director role, knowledge of CSV (Computer System Validation) is considered a key competency rather than a skill. It involves understanding regulatory requirements, validation processes, and documentation practices essential for ensuring computer systems meet quality standards. Proficiency in related tools and standards like GAMP or 21 CFR Part 11 is also important.
What are the most commonly searched types of Computer System Validation jobs? The most popular types of Computer System Validation jobs are:
Global Computer Validation Specialist

Global Computer Validation Specialist

Global Channel Management, Inc.

Marlborough, MA

$40/hr

Contractor

Posted 16 days ago

Job description

Company Description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation.  Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function.  Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. 


Job Description

Hands on position responsible for authoring test scripts and other
CSV documents required for the validation of GAMP 5 Category 4
(configurable off the shelf) computer systems.  Candidates should be
familiar with COTS systems used for clinical development and quality
activities in a pharmaceutical environment.  Work with business users
and Information Technology to ensure the systems remain in a validated
state through appropriate change control procedures. May require
participation in early morning and/or evening teleconferences with
global project teams.

  1. Create
    and/or review computer system validation test scripts, validation
    schedules, risk assessments, requirement specifications, protocols and
    reports, traceability matrices, and validation summary reports according
    to the timelines in the project plan.  Review applicable procedures and
    system training manuals as applicable. Participate in project team
    meeting. (85%)
  2. Document
    requirements for business requirements, system security, user roles,
    workflows, data flows, GxP requirements and how these systems fit into
    the larger IT infrastructure. (10%)
  3. Work
    with IT and User Groups to: (a) evaluate change control requests, (b)
    assess regulatory risk associated with such requests and (c) determine
    the corresponding validation requirements for such changes. (5%)
Qualifications
  • 2 - 3 years experience writing CSV test scripts, protocols and summary reports in global environments
  • Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline. 

Knowledge and skills (general and technical):

  • Sufficiently
    knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best
    practices for computerized system validation to complete tasks
  • Experience working with global teams particularly with team members from Japan
  • Understands lifecycle approach as well as risk based approach to validation
  • Generally familiar with GXP regulations particularly in the GCP and Quality areas
  • Able to work both independently and as a member of a cross-functional project team
  • Good written and oral communication skills
  • Good problem solving skills
  • Microsoft products such as Word, Excel, Project, and Visio.
  • Familiar
    with Information Technology principles, functionalities and
    capabilities of computer systems; and how computer systems relate to and
    integrate with larger corporate IT infrastructures
Additional Information

$40/hr

6 MONTHS +

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About Global Channel Management

Sourced by ZipRecruiter

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Global Channel Management understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at the same time requiring the best talent for the job. GCM's Ownership and Management teams have extensive Staffing, Recruiting, HR and Executive Leadership knowledge, Experience and Expertise. Our Understanding and Commitment to our Client's Satisfaction are key reasons GCM has been successful in establishing long term relationships.

Industry

Recruiting and staffing services

Company size

11 - 50 Employees

Headquarters location

Austell, GA, US

Year founded

2009

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