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Computer System Validation Csv Jobs (NOW HIRING)

Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. * Author and/or contribute to validation deliverables. * Ensure full ...

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

CA · On-site

Validation & CSV Support Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. Author and/or contribute to validation deliverables. Ensure full ...

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

Experience in the pharmaceutical, biotechnology, or medical device industry * 10+ years of experience in Computer System Validation (CSV) * Experience in FDA and/or global regulated environments with ...

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Computer System Validation Csv information

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

As of Jul 1, 2026, the average hourly pay for computer system validation csv in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

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

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What is a Computer System Validation (CSV) job?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are some typical challenges faced by Computer System Validation professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

What cities are hiring for Computer System Validation Csv jobs? Cities with the most Computer System Validation Csv job openings:
What are the most commonly searched types of Computer System Validation Csv jobs? The most popular types of Computer System Validation Csv jobs are:
What states have the most Computer System Validation Csv jobs? States with the most job openings for Computer System Validation Csv jobs include:
Infographic showing various Computer System Validation Csv job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.
Computer Systems Validation Specialist III

Computer Systems Validation Specialist III

lonza

Kittery, ME • On-site

Full-time

Retirement

This job post has expired today. Applications are no longer accepted.


Lonza rating

8.2

Company rating: 8.2 out of 10

Based on 41 frontline employees who took The Breakroom Quiz

29th of 73 rated pharmaceutical


Job description

Computer Systems Validation Specialist III

Location:Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.

The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.

What you will get:

  • A collaborative and inclusive work environment.

  • Opportunities for career growth and development.

  • Access to cutting-edge technologies and tools.

  • Competitive compensation and benefits package.

  • 401(k) matching plan.

  • Supportive leadership and mentoring.

  • Commitment to ethical and sustainable practices.

Our full list of global benefits can be found here:.

What you will do:

  • Perform all aspects of QMS process'–Change Control, Deviations,

  • CAPAs.

  • Perform Gap assessments to identify the gaps in processes andsuggest remediation plans. Initiate the right Quality records (Deviationsand CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead forprojects.

  • Author/Review/Approve allend to endComputer system validation life-

  • cycle deliverables/activities.

  • Schedule qualification activities and personnel to meet business,

  • manufacturing, engineering and quality objectives.

  • Revise and maintain SOPs to ensure continuous improvement and

  • compliance to GROUP/CORP procedures.

  • Perform review of Engineering documents (P&IDs, SOPs,Specifications, Submittals, etc.).

  • Support Validation requests as a CSV SME, during Customer auditsand inspections.

What we are looking for:

  • Bachelor's degree in computer science, engineering, or related field.

  • At least 3+ years of experience in computer systems validation.

  • 3+ years of Experience in working in a cGMP facility.

  • Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer.

  • Systems Validation (especially for analytical computerized systems).

  • Works independently and in teams.

  • Background in biotech, pharma, or medical device industry.

  • Ability to work independently and on-site in Portsmouth NH.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.


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