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Computer System Validation Csv Pharmaceutical Jobs

Valspec

IT Validation Lead (GxP / CSV)

Libertyville, IL · Hybrid

$65 - $80/hr

... of Computer System Validation (CSV) / IT validation experience in the pharmaceutical or life ... sciences industry * Demonstrated experience leading validation efforts and approving regulated ...

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

As of Jul 23, 2026, the average hourly pay for computer system validation csv pharmaceutical 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 is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are some common challenges faced by Computer System Validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional in the pharmaceutical industry, and why are they important?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is Computer System Validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
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Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in the United States as of July 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 75% In-person, and 25% 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

Kittery, ME • On-site

Other

Retirement

Posted 22 days ago

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

20th 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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