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Computer System Validation Jobs (NOW HIRING)

Compli

CSV Lead/ Computer System Validation Lead

Marietta, PA · On-site

$96K - $127K/yr

CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.

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How much do computer system validation jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for computer system validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 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 the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer Systems Validation Specialist III

Computer Systems Validation Specialist III

Lonza

Portsmouth, NH • On-site

Full-time

Retirement

This job post has expired 1 day ago. Applications are no longer accepted.

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

23rd of 74 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: https://www.lonza.com/careers/benefits.

What you will do:

  • Perform all aspects of QMS process' – Change Control, Deviations,
  • CAPAs.
  • Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects.
  • Author/Review/Approve all end to end Computer 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 audits and 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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