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Computer System Validation Director Jobs (NOW HIRING)

Inteldot

WI · On-site

Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ...

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

As of Sep 10, 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 is a computer system validation director?

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.

What are the key skills and qualifications needed to thrive as a computer system validation director?

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 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 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 cities are hiring for Computer System Validation Director jobs?

Cities with the most Computer System Validation Director job openings:

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Infographic showing various Computer System Validation Director job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

QC Informatics Specialist (Computer System Validation)

Coventry, RI

Pharmaron
Chemical Manufacturing • 10K+ employees
Learn more about Pharmaronexternal

$80K - $120K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 15 days ago

Job description

Position: Computer System Validation/QC Informatics Specialist

Salary Range: $80,000 - $120,000/yr.

Location: Coventry, RI (On-site)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

To support process chemistry and manufacturing activities through management of laboratory data software platforms and workflows. This role is positioned within the Quality Control & Analytical department to develop and support their requirements and workflows and to act as liaison with IT and QA to minimize downtime, improve effectiveness and maintain compliance related to laboratory data generation, storage, and use.

Key Responsibilities

  • With the support of the reporting manager in the Quality Control & Analytical department, lead laboratory improvement efforts related to laboratory information handling such as custom report generation, ELN, LIMS system configuration, data storage/organization, and pharmaceutical data workflows.
  • Liaising with appropriate technical and IT stakeholders to manage GxP software upgrades, installations, and roll outs to ensure business continuity and effectiveness are maintained and improved.
  • Author, review, and perform GxP qualification activities related to QCA as part of the Computer System Validation (CSV) life cycle e.g. GxP Risk & Impact Assessments, URS/FS, Qualification Plan, IQ, OQ, PQ, Requirement Tractability Matrix, Quality Summary Report, periodic reviews and decommissioning activities.
  • Demonstrating expertise in site-wide, complex software platforms e.g. NuGensis LMS, SDMS, ELN, Empower 3 etc. as well as various other standalone laboratory system software used within QCA and Process Chemistry.
  • Support System Owners within business functions with training end users in the use of the system.
  • Liaise between end users and IT to clearly communicate business priorities and ensure that appropriate resources are used to maintain ongoing business operations.
  • Build effective business relationships with all stakeholders.
  • Support departmental or site audits as directed by manager/supervisor as necessary

What We're Looking For

  • MSc or BSc in Chemistry, or Computer Science, or related fields with minimum of 5 years of GxP experience.
  • If qualified in chemistry or a related field, then strong experience in an IT supporting role must be demonstrated including a basic understanding of data structures, programming, and/or information systems.

If qualified in computer science or a related field, then strong experience in an analytical laboratory supporting role must be demonstrated including a basic understanding of common chemistry terminology, application, and laboratory workflows.

  • Direct experience with laboratory informatics (LIMS) systems.
  • Understanding of common GxP topics including QMS, ALCOA+, 21 CFR Part 11, and Data Integrity principles.
  • Evidence of ability to effectively work cross-functionally between IT and scientific teams
  • Working knowledge of applicable FDA, EMA, GAMP, and/or ICH guidance as it relates to data integrity.
  • Evidence of ability to manage stepwise implementation and qualification projects.
  • Good knowledge on pharmaceutical compliance and latest industry requirements.
  • Functional experience in the technical administration of complex laboratory informatics software platforms such as NuGenesis LMS, SDMS and ELN.
  • Effective written and oral communication skills, including the ability to effectively present complex information to colleagues.
  • Effective in managing multiple competing activities and delivering to timelines.
  • Ability to work professionally in a cross-functional environment and clearly reinterpret/translate concepts across IT and Laboratory staff.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

  • Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
  • 401(k) Retirement Plan with generous employer matching
  • Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
  • Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
  • 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
  • Employee Assistance Program (EAP), mental health resources, and wellness programs
  • Family-friendly benefits, including fertility support and maternity resources
  • Professional development and career growth opportunities within a leading global CRO/CDMO

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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