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Stage 4 Solutions · 9 hours ago

Computer System Validation Engineer – Pharma (Hybrid- Bothell, WA)

Seattle, WA

Full-time

Hybrid

Mid Level

$70/hr - $76.61/hr

4+ years exp

Stage 4 Solutions is seeking a Computer System Validation Engineer – Pharma for a global pharmaceutical client. The role involves leading and executing validation activities for GxP electronic systems and applications, ensuring compliance with relevant procedures and regulations throughout the validation lifecycle.

AdvertisingConsultingManagement ConsultingMarketing

Growth Opportunities

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

Qualification

Computer System ValidationManufacturing Execution SystemsGAMP / risk-based validationCGMP / GXP regulationsCSV documentation developmentIT service managementBachelor's degreeBusiness Quality Management Systems

Required

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. Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)

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.)

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)

Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience

Benefits

Health benefits

401K

Company

Stage 4 Solutions

Stage 4 Solutions is a management consulting firm that provides marketing solutions services.

Founded in 2001

Saratoga, California, USA

51-200 employees

https://www.stage4solutions.com

Funding

Current Stage

Growth Stage

Leadership Team

Niti Agrawal

CEO and Founder

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