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Senior Computer System Validation Csv Jobs in Seattle, WA

Evotec

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark ... Collaborate with cross-functional teams to execute complex Computer System Validation (CSV ...

Just - Evotec Biologics

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark ... Collaborate with cross-functional teams to execute complex Computer System Validation (CSV ...

Evotecgroup

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark ... Collaborate with cross-functional teams to execute complex Computer System Validation (CSV ...

Evotec

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark ... Collaborate with cross-functional teams to execute complex Computer System Validation (CSV ...

Systimmune

Director, Information Technology

Redmond, WA · On-site

$180K - $250K/yr

Lead computer system validation (CSV) and qualification activities for GxP-relevant systems ... Serve as the senior escalation point for critical IT issues and act as a hands-on leader who stays ...

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Senior Computer System Validation Csv information

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

As of Jul 31, 2026, the average hourly pay for senior computer system validation csv in Seattle, WA is $73.71, according to ZipRecruiter salary data. Most workers in this role earn between $58.80 and $83.70 per hour, depending on experience, location, and employer.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
What are the most commonly searched types of Computer System Validation Csv jobs in Seattle, WA? The most popular types of Computer System Validation Csv jobs in Seattle, WA are:
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Senior Computer System Validation Csv jobs near you

Computer System Validation Engineer

Alpha Consulting Corp.

Bothell, WA • On-site

Full-time

Re-posted 16 days ago

Job description

Job Summary:
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.
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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

Social media

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