Validation Engineer III

Employer: Gilead Sciences, Inc.
Location: Foster City
Salary: See job description.
Closing date: Sep 29, 2021

Discipline: Other, Legal/Regulatory Affairs
Position Type: Full Time
Job Type: Technician
Organization Type: All Industry, Pharma

Validation Engineer III
United States - California - La Verne

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. 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.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status.

Requirements (This posting is for multiple roles. The requirements listed are comprehensive and not required for each role.)

Responsibilities (include but are not limited to):

Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
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.
Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
Coordinates assigned projects and represents department on project teams.
May provide day-to-day guidance and training to validation technicians.
Serves as an information resource to validation technicians, contractors and vendors.
Resolves validation issues of moderate scope with limited direct supervision.

Requirements:

6+ years of relevant experience and bachelor's degree in engineering or physical science or related field.
4+ years of relevant experience and an MS.
2+ years or relevant experience and a PhD.
Working knowledge of the validation role inside a cGMP manufacturing; a history of working inside the regulations and requirements for biologics or pharmaceuticals.
Working knowledge of scientific and engineering principles in the biopharmaceutical industry.
Proven track record to create, review, and execute qualification protocols and associated validation lifecycle documentation (including VMP, reports and assessments), including identification and resolution of non-conformances /deviations.
Demonstrate the ability to translate system requirement specifications into executable validation protocols.

Experience with qualification of aseptic processing equipment primarily Isolator, Filler, Lyophilizer and Tank SIP, Dry Heat and Moist Heat Sterilization, media fill, classed areas and general temperature mapping.
Strong verbal, written, and interpersonal communication skills are required.
Investigation and report writing skills.
Be able to read and interpret drawings such as blueprints, PFDs, P&IDs.

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.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster: https://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf

Notice: Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Your rights under the Family and Medical Leave Act: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

Pay transparency nondiscrimination provision: https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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 jobs in the United States:
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:
Please log onto your Internal Career Site to apply for this job.

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---La-Verne/Validation-Engineer-III_R0021362-2

Validation Engineer III

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