Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
New
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
New
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
New
Ventura, 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 ...
Ventura, 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 ...
West Chester, OH · On-site
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, ...
West Chester, OH · On-site
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, ...
West Chester, OH · On-site
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, ...
West Chester, OH · On-site
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, ...
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
New
Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is ... as CSV project lead forprojects. * Author/Review/Approve allend to endComputer system validation ...
New
King Of Prussia, PA · Remote
$104K - $142K/yr
... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences * Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance * Strong ...
King Of Prussia, PA · Remote
$104K - $142K/yr
... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences * Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance * Strong ...
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 ...
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 ...
Fort Worth, TX · On-site
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.
Fort Worth, TX · On-site
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.
Canton, MA · On-site
The consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer system validation (CSV) methodologies and principles to perform CSV on ...
Canton, MA · On-site
The consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer system validation (CSV) methodologies and principles to perform CSV on ...
Portland, OR · On-site
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 ...
Quick apply
Portland, OR · On-site
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 ...
Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on the interpretation and application of global GxP regulations and guidance related to computerized ...
Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on the interpretation and application of global GxP regulations and guidance related to computerized ...
Hillsboro, OR · Remote
$75 - $84/hr
Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification. * Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity requirements.
Quick apply
Hillsboro, OR · Remote
$75 - $84/hr
Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification. * Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity requirements.
Indianapolis, IN · On-site
$98K - $129K/yr
We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This ...
Quick apply
Indianapolis, IN · On-site
$98K - $129K/yr
We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This ...
Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 ...
Quick apply
Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 ...
Conducting Computer System Validation (CSV) for OT systems * Implementing and managing audit trails and electronic records * Implementing Role-Based Access Control (RBAC) for OT systems * Working ...
Conducting Computer System Validation (CSV) for OT systems * Implementing and managing audit trails and electronic records * Implementing Role-Based Access Control (RBAC) for OT systems * Working ...
Princeton, NJ · On-site
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 ...
Princeton, NJ · On-site
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 ...
... validation exceptions/deviations for Computer and IT systems. b ... Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems. Schedules and executes ...
... validation exceptions/deviations for Computer and IT systems. b ... Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems. Schedules and executes ...
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
San Carlos, CA · Hybrid
$164K - $190K/yr
The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational ...
San Carlos, CA · Hybrid
$164K - $190K/yr
The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational ...
$29.57 - $33.76
4% of jobs
$33.76 - $37.96
18% of jobs
$38.92 is the 25th percentile. Wages below this are outliers.
$37.96 - $42.15
13% of jobs
$42.15 - $46.35
14% of jobs
The median wage is $47.05 / hr.
$46.35 - $50.55
9% of jobs
$50.55 - $54.74
5% of jobs
$54.74 - $58.94
7% of jobs
$58.94 - $63.13
4% of jobs
$63.25 is the 75th percentile. Wages above this are outliers.
$63.13 - $67.33
9% of jobs
$67.33 - $71.53
12% of jobs
$71.53 - $75.72
4% of jobs
$29
$51
$75
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.
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.
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.

Full-time
Retirement
This job post has expired today. Applications are no longer accepted.
8.2
Based on 41 frontline employees who took The Breakroom Quiz
29th of 73 rated pharmaceutical
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.
Sourced by ZipRecruiter