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Computer System Validation Csv Pharmaceutical Jobs in Raleigh, NC

Valspec

Validation Engineer I

Raleigh, NC · On-site

VALIDATION ENGINEER (CSV) Location: Raleigh-Durham, NC The ideal candidate is a recent engineering ... computer systems that manufacture pharmaceuticals, vaccines, cell and gene therapy products, and ...

Indivior

Senior Engineer, Validation

Raleigh, NC

Senior Engineer, Validation WHO WE ARE Indivior is a global pharmaceutical company working to help ... Working knowledge of process automation and computer system validation concepts, GAMP methodologies ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

MDAEdge

LabWare LIMS-LES Developer

Raleigh, NC · On-site

... integration. • Familiarity with system validation (CSV), change control, and regulatory ... Bachelor's degree in Computer Science, Life Sciences, or a related field. Preferred : • ...

NeoGenomics

Business Systems Analyst, LIMS

Durham, NC · On-site

... to computer system validation (CSV) documentation and testing Education, Experience & Qualifications: * Bachelor's Degree in Computer Science, Information Systems, Life Sciences, Chemistry, or ...

Syner-G

Sr. Validation Engineer

Raleigh, NC · On-site

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

GRIFOLS, S.A.

Manufacturing Digital Manager

Clayton, NC · On-site

Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations * Demonstrated experience implementing or sustaining EBR/MES platforms. Preferred * Experience ...

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Computer System Validation Csv Pharmaceutical information

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for computer system validation csv pharmaceutical in Raleigh, NC is $52.80, according to ZipRecruiter salary data. Most workers in this role earn between $40.67 and $62.64 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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For Computer System Validation Csv Pharmaceutical jobs in Raleigh, NC, the most frequently searched job titles are:

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The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Raleigh, NC are:

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Cities near Raleigh, NC with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $109,828 per year, or $52.8 per hour.

Sr/Principal Computer Systems Validation Specialist

KBI Biopharma, Inc.

Durham, NC

$133K - $183K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 21 days ago

KBI Biopharma rating

6.5

Company rating: 6.5 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls,CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technicalexpertise for all global software validation related matters, including assurance thatall aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.

Job Responsibilities:

  • Provide oversight of enterprise software validation from a global perspective.

  • Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.

  • Provide oversight and management to validation managed services for associated projects

  • Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.

  • Provide support for data integrity global initiatives.

  • Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software

This position will be based in Durham, NC and will require a regular site presence.

Minimum Requirements:

  • (Principal - BS/MS and 15+ years/ Senior - BS/MS and 8+ years) experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.

  • Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.

Salary Range:

$118,000 - $162,800 (Senior)

$133,000 - $183,700 (Principal)

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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