Computer System Validation Engineer (CSV)

Job Description

Title:: Computer System Validation Engineer (CSV)

Location :: Remote (Must be local to San Francisco, CA)

Duration:: 6+ Months

MOI :: Video

Visa :: NO H1B, NO OPT

Qualifications:

Expertise in ALCOA, GAMP 5, and 21 CFR Part 11 regulations for computerized systems within the life science industry.
Proficiency in Computer System Validation (CSV) practices and processes.
Experience in template creation to support GAMP 5 processes.
Experience in supplier assessment for non-product software.
Strong documentation skills for various validation documents.
Familiarity with software quality assurance practices and supplier audits. Exceptional organizational skills and attention to detail.
Effective communication and collaboration abilities.
Adaptability to evolving regulatory requirements and industry practices.
Experience with risk assessment methodologies in software validation.
Experience in managing and reviewing Standard Operating Procedures (SOPs) related to computer system validation is a plus.
Bachelor’s degree in a relevant field (e.g., Computer Science, Life Sciences, Engineering) or equivalent work experience.