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

Staffingine LLC

Silicon Validation Engineer

Raleigh, NC · On-site

Silicon Validation Engineer Job Location: Raleigh NC Job Type: Contract * You will be responsible ... Bachelor's degree in electrical engineering, Computer Engineering, or a related field. * 7+ years ...

Intellectt INC

"cleaning validation"

Holly Springs, NC · On-site

Role:CQV Engineer - Cleaning Validation Location: Holly Springs, NC Key Responsibilities: * Execute and document cleaning validation protocols per FDA/ICH guidelines (ALCOA principles). * Apply ...

Körber Group

Senior Application Architect

Apex, NC · On-site

... computer system validation documentation for pharmaceutical companies * Strong knowledge of MES, ERP, and Level 2 system architecture, with a broad understanding of related business functions

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How much do computer system validation jobs pay per hour?

As of Jun 7, 2026, the average hourly pay for computer system validation 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 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.

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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Raleigh, NC as of May 2026, with employment types broken down into 80% Full Time, 8% Part Time, 4% Temporary, and 8% Contract. Highlights an 100% In-person job distribution, with an average salary of $109,822 per year, or $52.8 per hour.

Biopharmaceutical CQV SPECIALIST

MMR Consulting

Raleigh, NC • On-site

Other

Posted 4 days ago

Job description

Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work will require working out of client's facilities.
The work will require working out of the client's facilities in Raleigh, North Carolina.
Responsibilities
  • Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
  • Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle
  • Able to perform field execution of qualification test cases and protocols
  • Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
  • Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
  • Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following - Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
  • Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
  • Engage other departments, as required, into design reviews and decisions.
  • Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
  • Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
  • Visit construction and installation sites, wearing necessary safety PPE.
  • You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
  • Supervise contractors during critical testing of system and equipment.
  • Other duties as assigned by client, and/or MMR, based on workload and project requirements.
  • As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable

Qualifications
  • 3+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
  • Experience with commissioning & qualification of equipment & facilities is required.
  • Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
  • Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ.
  • Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
  • Experience with commissioning and qualification of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
  • Experience with Qualification or Validation of clean utilities and ISO clean rooms.
  • Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
  • Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
  • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
  • Possess mentorship skills, to coach and develop junior and intermediate employees.
  • Engineering degree, preferably in Mechanical, Electrical or Chemical.
  • Travel may be required on occasion.
  • Ability to handle multiple projects and work in a fast-paced environment.
  • Strong multi-tasking skills

Compensation : 80,000$ - 100,000$ based on industry experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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