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Computer System Validation engineer

Computer System Validation engineer

Katalyst HealthCares & Life SciencesVacaville, CA
[job_card.full_time]
As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process contro...[show_more][last_updated.last_updated_30]
COMPUTER SCIENCE

COMPUTER SCIENCE

Santa Rosa Junior CollegeSonoma County, CA
[job_card.full_time] +1
Santa Rosa Junior College is currently accepting applications to establish a pool for part-time associate faculty assignments. Associate assignments are temporary, part-time or on-call.This job post...[show_more][last_updated.last_updated_30]
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Aviation Electronics, Electrical & Computer Systems Technician

Aviation Electronics, Electrical & Computer Systems Technician

US NavyVacaville, CA, United States
[job_card.full_time]
ABOUT Aviation Electronics, Electrical, and Computer Systems Technicians (AV) work on some of the most advanced aircraft systems in the world. They maintain, diagnose, and repair complex electrical ...[show_more][last_updated.last_updated_variable_days]
Computer System Validation engineer

Computer System Validation engineer

Katalyst HealthCares & Life SciencesVacaville, CA
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Summary :

As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA CFR Part , EU Annex , and other applicable regulations.

Roles & Responsibilities :

  • Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ / OQ / PQ protocols, and Summary Reports.
  • Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
  • Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
  • Provide training to stakeholders on validation requirements and best practices.
  • Maintain validation lifecycle documentation and change control records.

Education & Experience :

  • Experience with CSV in a regulated pharmaceutical or biotech environment.
  • Strong knowledge of GxP, FDA CFR Part , and EU Annex .
  • Proficiency in authoring and executing validation documentation.