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Computer System Validation Csv Pharmaceutical Jobs in Raleigh, NC

Novartis Group Companies

AS&T Specialist

Morrisville, NC · On-site

$89K - $166K/yr

... system validation (CSV) support, introduction of new analytical technologies, and readiness ... pharmaceutical or biotechnology operations. * Hands-on experience with complex analytical ...

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 ...

Corning

Division Quality Engineer I

Durham, NC · On-site

$69K - $89K/yr

Support the standardization of computer systems validation procedures, templates, and documentation ... Author, review, execute, and approve CSV lifecycle documentation, including: * Ensure computerized ...

Valspec

Validation Engineer - Kentucky

Raleigh, NC

... pharmaceutical manufacturing facility in Lexington, Kentucky. This consultant will lead validation activities supporting manufacturing suites, process equipment, and laboratory systems within a ...

Valspec

ERP (D365) Validation Consultant

Raleigh, NC · On-site +1

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... We partner with a variety of sectors, including pharmaceutical, biotech, manufacturing, and other ...

Valspec

ERP (D365) Validation Consultant

Durham, NC · On-site +1

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... We partner with a variety of sectors, including pharmaceutical, biotech, manufacturing, and other ...

Fujifilm

QC LIMS Developer

Research Triangle Park, NC

... Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals. Qualifications * Bachelor's in Computer Science/Information Systems ...

Fujifilm

QC LIMS Developer

Durham, NC · On-site

... Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals. Qualifications * Bachelor's in Computer Science/Information Systems ...

Fujifilm

ServiceNow, Product Owner

Holly Springs, NC · On-site

$46.75 - $64.25/hr

Ensure compliance in a regulated environment; lead/participate in Computer Software Validation (CSV ... systems in complex, matrixed organizations, with 3+ years directly administering and enhancing ...

Fujifilm

QC LIMS Developer

Research Triangle Park, NC · On-site

... Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals. Qualifications * Bachelor's in Computer Science/Information Systems ...

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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.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Raleigh, NC?

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

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Raleigh, NC look for?

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.

AS&T Specialist

Novartis Group Companies

Morrisville, NC • On-site

$89K - $166K/yr

Other

Medical, Life, Retirement, PTO

Posted 4 days ago

Job description

Job Description Summary

#LI-Onsite
Location: Morrisville, North Carolina
The AS&T Specialist will play a critical role in supporting the start-up and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, North Carolina. This position provides scientific analytical support across method validation, method transfer, analytical troubleshooting, equipment qualification, and commercial testing activities while ensuring the highest standards of quality, compliance, and data integrity.
Working within a growing site organization, the AS&T Specialist will support the implementation and lifecycle management of analytical methods, technologies, and laboratory equipment used to test pharmaceutical raw materials, intermediates, and finished products. The role will contribute to equipment qualification, calibration, maintenance, and technology implementation activities while partnering with cross-functional teams to support product transfers and laboratory readiness.
This is an exciting opportunity to help build the analytical capabilities and laboratory infrastructure supporting the future growth of the Morrisville manufacturing site.


Job Description

Key Responsibilities

  • Execute analytical method validation, transfer, optimization, and lifecycle management activities supporting pharmaceutical raw materials, intermediates, and finished products.

  • Provide scientific and technical support for analytical investigations, including OOS results, deviations, root cause analysis, troubleshooting activities, and CAPA development.

  • Serve as a technical owner for analytical laboratory equipment, coordinating qualification, calibration, maintenance, lifecycle management, and performance monitoring activities to ensure reliable and compliant laboratory operations.

  • Lead equipment qualification and implementation activities, including qualification planning, computerized system validation (CSV) support, introduction of new analytical technologies, and readiness activities associated with laboratory start-up and expansion.

  • Perform and support complex analytical testing utilizing technologies such as HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and physicochemical testing techniques.

  • Author, review, and maintain analytical documentation, including protocols, reports, specifications, SOPs, investigations, qualification documentation, and technical records in accordance with GxP requirements.

  • Support product transfers, validation programs, and implementation of new analytical methods and technologies required to advance the Morrisville site and future manufacturing operations.

  • Ensure compliance with cGxP, data integrity, regulatory, and Novartis quality standards while supporting audits, inspections, commercial release testing, and continuous improvement initiatives.

Essential Requirements

  • Bachelor's degree in Chemistry, Pharmacy, Microbiology, or another related scientific discipline with a minimum of 5 years of experience working in a cGMP laboratory environment supporting pharmaceutical or biotechnology operations.

  • Hands-on experience with complex analytical techniques and instrumentation, including HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and/or physicochemical testing.

  • Experience using LabWare LIMS and familiarity with building methods and utilizing Empower CDS.

  • Working knowledge of ICH Q2, ICH Q7, ICH Q10, GxP requirements, data integrity principles, and good documentation practices.

  • Demonstrated ability to troubleshoot analytical methods and laboratory instrumentation while supporting compliant laboratory operations and scientific investigations.

  • Strong communication, collaboration, and problem-solving skills, with the ability to identify key issues, adapt to changing priorities, and work effectively across cross-functional teams.

The salary for this position is expected to range between $89,600 and $166,400per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$89,600.00 - $166,400.00


Skills Desired

Collaboration, Communication, Data Integrity, Decision Making, Good Laboratory Practices (GLPs), Laboratory Standards, Laboratory Testing, Managing Ambiguity, Method Validation, Process Validation, Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Validation Activities

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