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Computer System Validation Director Jobs (NOW HIRING)

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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:

Computer System Validation Engineer

Scalence L.L.C.

Bothell, WA • On-site

Full-time

Posted 8 days ago


Job description

Job Summary:
Scalence L.L.C. is seeking a Computer System Validation Engineer to lead and execute validation activities for GxP electronic systems and applications. The role involves partnering with Business Owners, Technical Owners, and Quality to create and manage validation deliverables throughout the validation lifecycle.
Responsibilities:
• Author, review and/or approve applicable CSV documentation
• Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
• Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
• Other related duties as assigned
Qualifications:
Required:
• Strong Computer Systems Validation (CSV) experience
• Familiarity with Manufacturing Execution Systems (MES)
• Protocol drafting and execution, good communication
• Required to be onsite throughout UAT execution
• Ability to effectively communicate with both technical and non-technical team members
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
• Strong technical and problem-solving skills and the ability to work independently
• Demonstrated success working in a high-performing, business results-driven environment
• Understanding of computer system validation
• Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)
• Understanding of computer system validation (CSV)
• Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement)
• 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
• Strong knowledge on Manufacturing Execution System (MES) validation
• Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
• Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
Company:
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience. Founded in , the company is headquartered in Morristown, New Jersey, US, , with a team of 501-1000 employees. The company is currently Late Stage.