The Computer Systems Validation (CSV) Specialist, Level 2 Location : Portsmouth, NH. Relocation assistance is available for eligible candidates and their families. The Computer Systems Validation ...
The Computer Systems Validation (CSV) Specialist, Level 2 Location : Portsmouth, NH. Relocation assistance is available for eligible candidates and their families. The Computer Systems Validation ...
Computer Systems Validation (Analytical Equipment), Specialist IV Location : On-site, Portsmouth ... Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large ...
Computer Systems Validation (Analytical Equipment), Specialist IV Location : On-site, Portsmouth ... Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large ...
Computer Systems Validation (Analytical Equipment), Specialist IV Location : On-site, Portsmouth ... Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large ...
Computer Systems Validation (Analytical Equipment), Specialist IV Location : On-site, Portsmouth ... Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large ...
Computer System Validation Engineer
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Computer System Validation Engineer
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
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CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Senior Computer Systems Validation (CSV) Specialist Location: Charlton, MA or Goleta (Santa Barbara ... Management System and operational excellence. What You'll Do * Lead and manage the global CSV ...
Senior Computer Systems Validation (CSV) Specialist Location: Charlton, MA or Goleta (Santa Barbara ... Management System and operational excellence. What You'll Do * Lead and manage the global CSV ...
Senior Computer Systems Validation (CSV) Specialist Location: Charlton, MA or Goleta (Santa Barbara ... Management System and operational excellence. What You'll Do * Lead and manage the global CSV ...
Senior Computer Systems Validation (CSV) Specialist Location: Charlton, MA or Goleta (Santa Barbara ... Management System and operational excellence. What You'll Do * Lead and manage the global CSV ...
Laboratory Validation Specialist The Laboratory Validation Specialist is responsible for ... Computer System Validation (CSV) * 21 CFR Part 11 / EU Annex 11 * GAMP 5 guidelines * Data ...
Laboratory Validation Specialist The Laboratory Validation Specialist is responsible for ... Computer System Validation (CSV) * 21 CFR Part 11 / EU Annex 11 * GAMP 5 guidelines * Data ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Global Computer Validation Specialist
Marlborough, MA · On-site
$40/hr
Candidates should be familiar with COTS systems used for clinical development and quality ... Create and/or review computer system validation test scripts, validation schedules, risk ...
Global Computer Validation Specialist
Marlborough, MA · On-site
$40/hr
Candidates should be familiar with COTS systems used for clinical development and quality ... Create and/or review computer system validation test scripts, validation schedules, risk ...
Our client, a world leader in biotechnology and life sciences, is looking for a " Senior Computer System Validation (CSV) Consultant " based out of San Diego, CA . Job Duration: Long Term Contract ...
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Our client, a world leader in biotechnology and life sciences, is looking for a " Senior Computer System Validation (CSV) Consultant " based out of San Diego, CA . Job Duration: Long Term Contract ...
Analytical Validation Specialist IV Summary: * Analytical Validation specialist IV will lead ... Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of ...
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Analytical Validation Specialist IV Summary: * Analytical Validation specialist IV will lead ... Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of ...
Sr/Principal Computer Systems Validation Specialist
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Sr/Principal Computer Systems Validation Specialist
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Quality Validation Specialist - TPI TerraPower Isotopes (TPI) is seeking an experienced Quality ... Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic ...
Quality Validation Specialist - TPI TerraPower Isotopes (TPI) is seeking an experienced Quality ... Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
VALIDATION - Validation Specialist
Lawrenceville, NJ · On-site
$81.05 - $85.96/hr
Validation Specialist Job Number: 26-00778 Be part of a company that delivers life-changing health ... This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems ...
VALIDATION - Validation Specialist
Lawrenceville, NJ · On-site
$81.05 - $85.96/hr
Validation Specialist Job Number: 26-00778 Be part of a company that delivers life-changing health ... This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems ...
VALIDATION - Validation Specialist
$81.05 - $85.96/hr
Validation Specialist Job Number: 26-00778 Be part of a company that delivers life-changing health ... This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems ...
VALIDATION - Validation Specialist
$81.05 - $85.96/hr
Validation Specialist Job Number: 26-00778 Be part of a company that delivers life-changing health ... This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems ...
Quality Validation Specialist - TPI TerraPower Isotopes (TPI) is seeking an experienced Quality ... Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic ...
Quality Validation Specialist - TPI TerraPower Isotopes (TPI) is seeking an experienced Quality ... Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic ...
Global Computer Validation Specialist
Marlborough, MA · On-site
$45/hr
Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or ... Understands lifecycle approach as well as risk based approach to validation * Generally familiar ...
Global Computer Validation Specialist
Marlborough, MA · On-site
$45/hr
Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or ... Understands lifecycle approach as well as risk based approach to validation * Generally familiar ...
Computer System Validation Specialist information
See salary details
$10.58 - $17.44
2% of jobs
$17.44 - $24.30
9% of jobs
$24.30 - $31.16
1% of jobs
$31.16 - $38.02
4% of jobs
$42.19 is the 25th percentile. Wages below this are outliers.
$38.02 - $44.89
15% of jobs
$44.89 - $51.75
9% of jobs
The median wage is $57.47 / hr.
$51.75 - $58.61
13% of jobs
$64.07 is the 75th percentile. Wages above this are outliers.
$58.61 - $65.47
29% of jobs
$65.47 - $72.33
12% of jobs
$72.33 - $79.20
2% of jobs
$79.20 - $86.06
5% of jobs
$10
$54
$86
How much do computer system validation specialist jobs pay per hour?
What are the key skills and qualifications needed to thrive as a Computer System Validation Specialist, and why are they important?
What are some common challenges faced by Computer System Validation Specialists during project implementation?
What Does a Computer System Validation Specialist Do?
A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality. As a CSV specialist, your responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. You also review test results and identify areas of improvement to implement changes. Other duties include providing technical expertise to customers and the validations department while communicating the validation plan and creating protocols. You may also ensure that each product is compliant with Current Good Manufacturing Practice (CGMP), Good Automated Manufacturing Practice (GAMP), and Code of Federal Regulations.
What does a Computer System Validation Specialist do?
What is the difference between Computer System Validation Specialist vs Quality Assurance Specialist?
| Aspect | Computer System Validation Specialist | Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP, 21 CFR Part 11, CSV-specific training | ISO 9001, Six Sigma, QA certifications |
| Work Environment | Pharmaceutical, biotech, regulated industries | Manufacturing, software, healthcare sectors |
| Employer & Industry Usage | Regulated industries requiring compliance documentation | Broadly used across industries for process quality |
The Computer System Validation Specialist focuses on ensuring computer systems meet regulatory standards through validation processes, primarily in regulated industries like pharma and biotech. In contrast, the Quality Assurance Specialist oversees overall quality processes, including audits and compliance, across various sectors. While both roles emphasize compliance and documentation, the CSV Specialist is more technical and specific to computer systems validation, whereas the QA Specialist has a broader scope in quality management.
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Full-time
Posted 17 days ago
Lonza rating
8.1
Based on 40 frontline employees who took The Breakroom Quiz
31st of 71 rated pharmaceutical
Job description
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Computer Systems Validation (CSV) Specialist, Level 2 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members and will be involved as the QA CSV representative during small and large-scale projects.
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.
- Supportive leadership and mentoring.
- Commitment to ethical and sustainable practices.
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do
- Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.
- Execute all responsibilities as CSV project lead for simple projects.
- Oversee/perform all CSV qualification activities for DeltaV and Syncade systems.
- Perform Validation Maintenance of computerized systems.
- Review/Revise CSV SOPs.
- Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc..)
- Assist with audits and inspections.
What we are looking for
- Bachelor's degree in computer science, engineering, or related field.
- 0-4 years experience in Computer Systems Validation
- 1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferred.
- Experience leading projects and managing CAPAs and deviations.
- Background in biotech, pharma, or medical device industry.
- Strong attention to detail and ability to meet deadlines.
- 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-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.
About Lonza
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