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Computer Systems Validation Jobs in Houston, TX (NOW HIRING)

Karls Technology

Be Seen First

Computer Technician

Houston, TX · On-site

$40K - $48K/yr

... smart TVs, home security systems). You will also assist in setting up, configuring and ... Possess a valid driver's license, maintain valid insurance, a good driving record, have a reliable ...

New

Karls Technology

Be Seen First

Computer Technician

Spring, TX · On-site

$40K - $48K/yr

... smart TVs, home security systems). You will also assist in setting up, configuring and ... Possess a valid driver's license, maintain valid insurance, a good driving record, have a reliable ...

EBryit Inc

Computer Technician

Rosenberg, TX · On-site

$18 - $20/hr

Imaging, data migration, troubleshooting of computer systems. * Naming a computer and joining a ... Valid Drivers license and State minimum auto insurance. Job Type: Contract.

Cellipont Bioservices

Validation Engineer

Spring, TX · On-site

Support GMP validation projects of low to medium complexity (equipment, computerized systems ... Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.

Ankura

Model Validation Director

Houston, TX · On-site +1

The Model Validation Director is expected to lead and execute model validation testing processes on ... Computer Science, Management Information Systems, or Statistics/Mathematics. * Experience with data ...

ZT Auto

Service Advisor

Alvin, TX · On-site

... computer systems - Valid driver's license and a clean driving record Join our team and be part of a company that values integrity, teamwork, and continuous growth. We offer a supportive work ...

ZT Automotive

Service Advisor

Alvin, TX · On-site

... computer systems - Valid driver's license and a clean driving record Join our team and be part of a company that values integrity, teamwork, and continuous growth. We offer a supportive work ...

Ron Carter Chevrolet

Service Advisor

Alvin, TX

... computer systems - Valid driver's license and a clean driving record Join our team and be part of a company that values integrity, teamwork, and continuous growth. We offer a supportive work ...

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All JobsComputer Systems Validation JobsComputer Systems Validation Jobs in Houston, TX

Computer Systems Validation information

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$10

$51

$82

How much do computer systems validation jobs pay per hour?

As of Jul 1, 2026, the average hourly pay for computer systems validation in Houston, TX is $51.87, according to ZipRecruiter salary data. Most workers in this role earn between $39.95 and $61.54 per hour, depending on experience, location, and employer.

What is the work of computer system validation?

Computer Systems 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 helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of a CSV engineer?

A Computer Systems Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications in validation or quality assurance and proficiency with regulatory standards like FDA or GxP can influence compensation levels.

What are the key skills and qualifications needed to thrive in Computer Systems Validation, and why are they important?

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements such as FDA or EMA guidelines. The field offers steady employment opportunities, especially for professionals with certifications like GAMP or 21 CFR Part 11 knowledge.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

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 such as SystemVerilog and UVM.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
What are popular job titles related to Computer Systems Validation jobs in Houston, TX? For Computer Systems Validation jobs in Houston, TX, the most frequently searched job titles are:
What job categories do people searching Computer Systems Validation jobs in Houston, TX look for? The top searched job categories for Computer Systems Validation jobs in Houston, TX are:
What cities near Houston, TX are hiring for Computer Systems Validation jobs? Cities near Houston, TX with the most Computer Systems Validation job openings:
Computer Systems Validation jobs near you
Lead Computer Systems Validation (CSV) Engineer (W)

Lead Computer Systems Validation (CSV) Engineer (W)

Cellipont Bioservices

The Woodlands, TX • On-site

$93K - $123K/yr

Full-time

Medical, Retirement, PTO

Posted 10 days ago

Job description

Developing and Manufacturing your Cell Therapies from Benchtop to Bedside.
Job Summary
Cellipont Bioservices is growing, and we are looking for a Lead CSV Engineer who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The Lead CSV Engineer will lead the development and execution of risk-based CSV strategies for new system implementations, software upgrades, configuration changes, remediation activities, and lifecycle maintenance. This individual will be responsible for coordinate and oversee CSV deliverables, including system assessments, user requirements, risk assessments, data integrity and electronic records/electronic signatures assessments, configuration specifications, validation protocols, traceability matrices, and validation summary reports.
The Lead CSV Engineer will ensure computerized systems are implemented, maintained, and modified in compliance with internal procedures, client requirements, and applicable regulatory expectations, including 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based validation practices. This individual will work closely with Validation, Quality Assurance, Facilities & Engineering, Automation/OT, IT, Manufacturing, MSAT, Quality Control, clients, and vendors to manage project deliverables, resolve technical issues, assess risk, support timely system release, and provide technical guidance to developing engineers and cross-functional teams.
The Role
  • Primary responsibility is to lead CSV strategy and execution for GMP computerized systems supporting manufacturing, laboratory, facilities, automation, quality, and supporting infrastructure.
  • Serve as the CSV subject matter expert for assigned systems, capital projects, client programs, change controls, investigations, and remediation activities.
  • Collaborates cross-functionally with Quality Assurance, Facilities & Engineering, Automation/OT, IT, Manufacturing, MSAT, Quality Control, clients, and vendors to coordinate project activities, resolve issues, and support timely release of computerized systems.
  • Develop risk-based validation approaches based on intended use, system complexity, patient safety, product quality, data integrity, and electronic record/electronic signature requirements.
  • Define and execute appropriate testing strategies for new implementations, software upgrades, configuration changes, interfaces, data migrations, backup/restore activities, access controls, audit trails, and disaster recovery activities.
  • Partner with Automation/OT and IT to assess system architecture, data flows, interfaces, user access, audit trails, infrastructure controls, backup and recovery, and cybersecurity considerations.
  • Identify compliance risks and escalate to management with remediation proposal and lead solution implementation.
  • Lead CSV impact assessments for change controls and determine required documentation, testing, approvals, and implementation activities.
  • Provide technical support for deviations, investigations, CAPAs, audit responses, and system remediation activities involving computerized systems.
  • Review validation deliverables and provide technical guidance to junior engineers and cross-functional teams on CSV expectations, documentation quality, risk-based decision-making, and regulatory requirements.
  • Support the development and continuous improvement of CSV procedures, templates, work instructions, and lifecycle standards.
  • Supports and/or leads client on-site audits and participates in on-site technical visits.
  • Support regulatory (i.e. FDA, EMA) inspections.
  • Maintains systems used for tracking various GMP manufacturing-associated support activities.
  • Generation and/or revise SOP documents following cGMPs.
  • Maintain current knowledge of applicable cGMP regulations, regulatory guidance, and industry standards relevant to computerized systems, including FDA and EU requirements, 21 CFR Part 11, EU GMP Annex 11, data integrity principles, ICH guidance, and ISPE GAMP guidance.

The Candidate
  • BS.in Engineering, Computer Science, Life Sciences or another related technical discipline with a minimum 6 years of experience within the biopharmaceutical or regulated pharmaceutical industry (previous CDMO experience is a plus).
  • Experience in cell therapy, gene therapy, biologics, aseptic manufacturing, CDMO, or other fast-paced GMP manufacturing environments preferred.
  • Strong knowledge of computerized system lifecycle management, risk-based validation, data integrity, electronic records/electronic signatures, requirements development, testing strategy, traceability, and validation summary reporting.
  • Demonstrated ability to mentor engineers, establish technical strategy, review complex validation documentation, and provide leadership without direct management authority.
  • Experience working with Automation/OT and IT infrastructure, including servers, virtual machines, networked systems, data storage, backups, system restoration, disaster recovery, and cybersecurity controls preferred.
  • Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
  • Working knowledge of 21 CFR Part 11; 21 CFR Parts 210 and 211, including 21 CFR §211.68; EU GMP Annex 11 and Annex 15; FDA data integrity expectations; ICH Q9(R1); ALCOA+ principles; and industry guidance such as ISPE GAMP 5 and ASTM E2500.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients
  • Able to work in a team setting and independently under minimum supervision
  • Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel
  • Requires the ability to produce quality results in a fast-paced environment to meet client deadlines
  • Able to communicate effectively orally and written with all levels of personnel and regulatory inspectors

Position Benefits
  • Opportunities for career growth within an expanding team
  • Defined career path and annual performance review & feedback process
  • Cross-functional exposure to other areas of within the organization
  • Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
  • 401K strong employer match
  • Tuition Reimbursement
  • Employee Referral Bonuses
  • Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
  • Gain experience in the cutting-edge cell therapy space

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.

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