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Computer System Validation Jobs in Cary, NC (NOW HIRING)

Valspec

Validation Engineer (CQV)

Holly Springs, NC

Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...

Valspec

Validation Engineer (CQV)

Raleigh, NC

Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...

Novartis

Validation Engineer III

Durham, NC

$183K/yr

Support computer systems validation activities for global systems and applications * Collaborate with cross-functional teams to support audits, inspections, and project execution Essential ...

KBI Biopharma

ELN Administrator

Durham, NC · On-site

... to computer system validation and compliance. • Able to react to change productively and handle other essential tasks as assigned. Qualifications : Required : • Bachelor's degree in computer ...

Oxford Biomedica

Validation Engineer III

Durham, NC

Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities. * Development of Validation Plans and Validation Plan ...

New

Oxford Biomedica

Validation Engineer III

Durham, NC · On-site

Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities. * Development of Validation Plans and Validation Plan ...

Kelly Services

Quality Validation Manager

Raleigh, NC · On-site

$135K/yr

Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities ...

KBI Biopharma, Inc.

ELN Administrator

Durham, NC

$84K - $115K/yr

Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and ...

KBI Biopharma, Inc.

ELN Administrator

Durham, NC · On-site

$84K - $115K/yr

Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Jul 20, 2026, the average hourly pay for computer system validation in Cary, NC is $50.32, according to ZipRecruiter salary data. Most workers in this role earn between $38.75 and $59.66 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 job?

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 the Computer System Validation position, 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.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Cary, NC as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $104,669 per year, or $50.3 per hour.
Validation Engineer (CQV)

Validation Engineer (CQV)

Valspec

Holly Springs, NC

Full-time

Medical, Retirement

Posted 12 days ago

Job description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Validation Engineer (CQV)

Location: Raleigh-Durham area, NC

Position Overview

We are seeking an experienced Validation Engineer (CQV) to support commissioning, qualification, and startup activities for a large-scale biopharmaceutical manufacturing facility. This role will focus on downstream process systems and requires strong hands-on field execution, system troubleshooting, and automation verification experience in a GMP-regulated environment.

Key Responsibilities

  • Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections to confirm system accuracy and readiness ahead of commissioning and startup.
  • Lead and execute mechanical completion walkdowns and turnover package (TOP) reviews, ensuring construction quality, punch list closure, calibration records, weld documentation, and redline updates are complete.
  • Support commissioning readiness by validating system boundaries, flow paths, and equipment installation in alignment with design documentation.
  • Execute commissioning and qualification (CQV) activities for downstream process equipment including:
    • Chromatography skids
    • Ultrafiltration/Diafiltration (UF/DF) systems
    • Viral filtration systems
    • Depth filtration units
    • Buffer preparation vessels
    • Product hold tanks
  • Perform field startup and functional testing of chromatography systems, including:
    • Flow path verification
    • Valve sequencing checks
    • Conductivity and pressure monitoring
    • Automation functionality validation
  • Conduct Operational Qualification (OQ) testing for automated systems using DeltaV, including:
    • Loop checks and I/O verification
    • Interlock and permissive testing
    • Alarm challenge testing
    • Control logic and sequence verification under live conditions
  • Verify process alarms, interlocks, permissives, and emergency shutdown functions through field execution and control system testing.
  • Perform detailed P&ID walkdowns and field verification of valves, instruments, and process flow to support system turnover, TOP approval, and final acceptance.
  • Identify and troubleshoot startup issues related to:
    • Automation logic and control sequences
    • Valve sequencing and flow path discrepancies
    • Equipment integration and skid interfaces
    • Cleaning cycle performance
  • Collaborate cross-functionally with engineering, construction, and operations teams to maintain project timelines and ensure successful system startup.

Required Qualifications

  • Bachelor's degree in Engineering (Chemical, Mechanical, or related discipline) or equivalent industry experience
  • 5+ years of experience in CQV, commissioning, or validation within biopharmaceutical or life sciences manufacturing
  • Hands-on experience with downstream processing equipment, especially chromatography and filtration systems
  • Strong knowledge of cGMP requirements, commissioning processes, and validation lifecycle
  • Experience executing OQ protocols and field testing activities
  • Familiarity with DeltaV or similar DCS platforms (Emerson experience preferred)
  • Proficiency in reading and interpreting P&IDs, isometrics, and technical drawings
  • Demonstrated ability to work in a fast-paced startup environment with significant field presence

Preferred Qualifications

  • Previous experience supporting greenfield or large-scale capital projects
  • Strong troubleshooting and problem-solving skills in live plant environments
  • Experience with automation systems integration and process control verification
  • Ability to manage multiple systems and priorities during commissioning/startup phases

Work Environment

  • Primarily field-based role with significant time in manufacturing and construction areas
  • Requires coordination with multiple stakeholders across CQV, engineering, and operations
  • May involve extended hours during critical commissioning and startup windows

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

  • Premium medical coverage
  • 401(k) with company match
  • Tuition reimbursement
  • Unique performance incentives
  • And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.