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Computer Systems Validation Engineer II

Employer
Gilead Sciences, Inc.
Location
Oceanside, CA
Start date
Jul 26, 2022

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Job Details


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.


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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