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Director Computer System Validation Csv Jobs in Seattle, WA

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

New

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

New

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

Redmond, WA ยท 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 ยท 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 ...

Director, Information Technology

Redmond, WA ยท On-site

$180K - $250K/yr

Direct all IT operations and infrastructure--including servers, networks, storage, cloud ... Lead computer system validation (CSV) and qualification activities for GxP-relevant systems ...

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Director Computer System Validation Csv information

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

As of Jul 31, 2026, the average hourly pay for director computer system validation csv in Seattle, WA is $58.95, according to ZipRecruiter salary data. Most workers in this role earn between $44.33 and $73.32 per hour, depending on experience, location, and employer.
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Computer System Validation Engineer

Alpha Consulting Corp.

Bothell, WA โ€ข 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:
โ€ข Author, review and/or approve applicable CSV documentation
โ€ข Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
โ€ข Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
โ€ข Other related duties as assigned
Qualifications:
Required:
โ€ข Strong Computer Systems Validation (CSV) experience
โ€ข Familiarity with Manufacturing Execution Systems (MES)
โ€ข Protocol drafting and execution, good communication
โ€ข Required to be onsite throughout UAT execution
โ€ข Ability to effectively communicate with both technical and non-technical team members
โ€ข Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
โ€ข Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
โ€ข Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
โ€ข Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
โ€ข Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
โ€ข Strong technical and problem-solving skills and the ability to work independently
โ€ข Demonstrated success working in a high-performing, business results-driven environment
โ€ข Understanding of computer system validation
โ€ข Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)
โ€ข Understanding of computer system validation (CSV)
โ€ข 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)
โ€ข 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
โ€ข Strong knowledge on Manufacturing Execution System (MES) validation
โ€ข Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
โ€ข 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.

Alpha Consulting logo

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

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