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Computer System Validation Jobs in North Carolina

PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

$120K - $140K/yr

Support Computer System Validation (CSV) activities. * Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle. * Collaborate with cross-functional ...

New

Pinnaql

Validation Engineer

New Albany, OH

The role demands deep technical expertise across the full validation lifecycle including URS development, FAT/SAT execution, and Computer System Validation (CSV) as well as hands-on experience with ...

ALLIANCE BIOTECH SOLUTIONS LLC

CSV Engineer

Raleigh, NC · On-site

Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data ...

Reckitt

CSV - Quality Systems Specialist

Wilson, NC · On-site

$85K - $127K/yr

Develop and execute Computer System Validation (CSV) deliverables, including URS, FRS, IQ/OQ/PQ protocols, validation reports, periodic reviews, and revalidation activities. * Ensure compliance with ...

Reckitt

CSV - Quality Systems Specialist

Wilson, NC

$85K - $127K/yr

Develop and execute Computer System Validation (CSV) deliverables, including URS, FRS, IQ/OQ/PQ protocols, validation reports, periodic reviews, and revalidation activities. * Ensure compliance with ...

Intellectt INC

Validation Lead

Raleigh, NC · On-site

The role will be responsible for leading equipment qualification, process validation, cleaning validation, computerized system validation support, and compliance documentation. The Validation Lead ...

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Computer System Validation information

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$9

$49

$78

How much do computer system validation jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for computer system validation in North Carolina is $49.36, according to ZipRecruiter salary data. Most workers in this role earn between $38.03 and $58.56 per hour, depending on experience, location, and employer.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

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 GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in North Carolina as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $102,679 per year, or $49.4 per hour.

Senior Validation Engineer

PSC Biotech

Durham, NC • On-site

$120K - $140K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

New

Job description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are seeking an experienced Senior Validation Engineer to support commissioning, qualification, and validation activities for laboratory equipment, computerized systems, and analytical instrumentation within a regulated pharmaceutical or biotechnology environment. This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity, and regulatory requirements.
  • Lead and execute commissioning, qualification, and validation activities for laboratory equipment, analytical instruments, utilities, and computerized systems.
  • Develop, review, and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
  • Author, execute, and review validation documentation within the KNEAT platform.
  • Support Computer System Validation (CSV) activities.
  • Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle.
  • Collaborate with cross-functional stakeholders to ensure validation activities are executed on schedule and in compliance with site procedures.
  • Support deviation investigations, CAPAs, change controls, and impact assessments associated with validation activities.
  • Provide technical leadership and mentorship to junior validation engineers and project team members.
  • Support internal audits, client audits, and regulatory inspections as needed.
  • Ensure all validation documentation is complete, accurate, and inspection-ready.

Requirements
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
  • Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
  • Demonstrated experience with laboratory equipment qualification and analytical instrument validation.
  • Strong Computer System Validation (CSV) experience supporting regulated computerized systems.
  • Hands-on experience using KNEAT for protocol development, execution, review, approval, and lifecycle management.
  • Extensive knowledge of validation lifecycle activities, including:
    • Risk Assessments
    • Validation Plans
    • IQ/OQ/PQ Execution
    • Traceability Management
    • Validation Reporting
    • Change Control
    • Deviation Management
  • Thorough understanding of cGMP regulations, FDA requirements, GAMP 5, 21 CFR Part 11, and data integrity principles.
  • Strong technical writing and documentation skills.
  • Ability to independently manage complex validation projects in a fast-paced environment.
  • Excellent communication, stakeholder management, and cross-functional collaboration skills.
  • Experience supporting regulatory inspections and audit readiness activities preferred.
  • Must be authorized to work in the U.S. No C2C at this time.


Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more.
  • 401(k) and 401(k) matching
  • PTO, Sick Time, and Paid Holidays
  • Education Assistance
  • Pet Insurance
  • Discounted rate at Anytime Fitness
  • Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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