Computer Systems Validation Engineer II

Oceanside, CA
Apr 27, 2022
Required Education
High School or equivalent
Position Type
Full time

Computer Systems Validation Engineer II

Specific Job Responsibilities
  • Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
  • Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
  • Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
  • May also investigate and trouble-shoot problems which occur and determine solutions.
  • Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
  • Maintains all documentation pertaining to validation.
  • Will assist in developing procedures and/or protocols.
  • Coordinates contract personnel through completion of assignments.
  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
  • May provide day-to-day guidance and training to other validation technicians.
  • Serves as an information resource to validation technicians, contractors and vendors.
  • Resolves validation issues of moderate scope with limited direct supervision.

Knowledge, Education & Experience
  • A High School Diploma with 6+ years of relative experience OR an Associates Degree with 5+ years of relative experience OR A Bachelor's Degree with 4+ years of relevant experience or a Master's Degree (M.S./MBA)with 2+ years of relevant experience.
  • Understanding and application of validation principles, concepts, practices, and standards.
  • Working knowledge of current Good Manufacturing Practices (GMPs).
  • Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
  • Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
  • Previous experience having worked in a GMP Clinical Manufacturing facility is preferred.
  • Strong verbal, written, and interpersonal communication skills.
  • Proficient in Microsoft Office applications.

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About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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