Required : • Strong Computer Systems Validation (CSV) experience • Familiarity with Manufacturing Execution Systems (MES) • Protocol drafting and execution, good communication • Required to ...
Required : • Strong Computer Systems Validation (CSV) experience • Familiarity with Manufacturing Execution Systems (MES) • Protocol drafting and execution, good communication • Required to ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role involves leading and executing validation activities for GxP electronic systems and ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role involves leading and executing validation activities for GxP electronic systems and ...
Computer System Validation Engineer- Pharma (Hybrid- Bothell, WA)
Bothell, WA · On-site
$70 - $76.61/hr
Computer System Validation Engineer - Pharma (Hybrid- Bothell, WA) We are seeking a Computer System ... The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of ...
Quick apply
Computer System Validation Engineer- Pharma (Hybrid- Bothell, WA)
Bothell, WA · On-site
$70 - $76.61/hr
Computer System Validation Engineer - Pharma (Hybrid- Bothell, WA) We are seeking a Computer System ... The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of ...
IT CSV Engineer
Redmond, WA · On-site
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
Redmond, WA · On-site
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
Redmond, WA · On-site
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
Redmond, WA · On-site
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
Senior Validation Manager/SME
Seattle, WA · On-site
Computer System Validation (CSV - GAMP 5, 21 CFR Part 11) * Shipping / Distribution Validation * Proven leadership and team management experience * Deep understanding of FDA 21 CFR, EU GMP, and ICH ...
Quick apply
Senior Validation Manager/SME
Seattle, WA · On-site
Computer System Validation (CSV - GAMP 5, 21 CFR Part 11) * Shipping / Distribution Validation * Proven leadership and team management experience * Deep understanding of FDA 21 CFR, EU GMP, and ICH ...
IT CSV Engineer
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
IT CSV Engineer
$115K - $135K/yr
Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
The ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related ...
Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements. * Strong attention to detail ...
Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements. * Strong attention to detail ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Cyber Resiliency Manager
Bothell, WA · On-site
$124K - $167K/yr
Collaborate with Quality and Validation teams on computer system validation (CSV/CSA) activities that intersect with cybersecurity. * Maintain documentation and records to support regulatory ...
Cyber Resiliency Manager
Bothell, WA · On-site
$124K - $167K/yr
Collaborate with Quality and Validation teams on computer system validation (CSV/CSA) activities that intersect with cybersecurity. * Maintain documentation and records to support regulatory ...
Computer System Validation Csv information
See Seattle, WA salary details
$33.65 - $38.42
4% of jobs
$38.42 - $43.20
18% of jobs
$44.29 is the 25th percentile. Wages below this are outliers.
$43.20 - $47.97
13% of jobs
$47.97 - $52.75
14% of jobs
The median wage is $53.54 / hr.
$52.75 - $57.52
9% of jobs
$57.52 - $62.30
5% of jobs
$62.30 - $67.07
7% of jobs
$67.07 - $71.85
4% of jobs
$71.98 is the 75th percentile. Wages above this are outliers.
$71.85 - $76.62
9% of jobs
$76.62 - $81.40
12% of jobs
$81.40 - $86.17
4% of jobs
$33
$58
$86
How much do computer system validation csv jobs pay per hour?
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.
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Full-time
Posted 11 days ago
Job description
Alpha Consulting Corp. is seeking a Computer System Validation Engineer to lead and execute validation activities for GxP electronic systems and applications. This role involves partnering with Business Owners and Technical Owners to create and manage validation deliverables throughout the validation lifecycle.
Responsibilities:
• Author, review and/or approve applicable CSV documentation
• Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
• Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
• Other related duties as assigned
Qualifications:
Required:
• Strong Computer Systems Validation (CSV) experience
• Familiarity with Manufacturing Execution Systems (MES)
• Protocol drafting and execution, good communication
• Required to be onsite throughout UAT execution
• Ability to effectively communicate with both technical and non-technical team members
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
• Strong technical and problem-solving skills and the ability to work independently
• Demonstrated success working in a high-performing, business results-driven environment
• Understanding of computer system validation
• Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)
• Understanding of computer system validation (CSV)
• Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement)
• 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
• Strong knowledge on Manufacturing Execution System (MES) validation
• Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
• Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
Company:
Alpha Consulting Corp. has been exceeding expectations in the IT, pharmaceutical, and clinical staffing business since 1994. Founded in 1994, the company is headquartered in East Brunswick, USA, with a team of 201-500 employees. The company is currently Growth Stage.
About Alpha Consulting
Sourced by ZipRecruiter
Alpha Consulting is headquartered in East Brunswick, NJ, US and operates in the consulting sector. As a high-visibility consultant in the IT and pharmaceutical services industry, they deliver comprehensive project, process, and applications management solutions to businesses across these sectors. Empowering their clients to achieve their objectives through innovative and cost-effective strategies is the core belief of Alpha. Their mission is to offer experienced consulting and IT services that help clients attain their business objectives by seamlessly bridging the gap between business goals and technology implementation.
Industry
Recruiting and staffing services
Company size
201 - 500 Employees
Headquarters location
East Brunswick, NJ, US
Year founded
1994