Senior Validation Engineer I

Location
Foster City
Salary
See job description.
Posted
October 10 2021
Ref
R0021236
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician


Senior Validation Engineer I
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

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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.

The Senior Validation Engineer I reports to the Senior Validation Manager.

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

Specific Responsibilities
  • Serve as the validation lead of cross functional team and able to provide guidance during planning, designing and development of projects.
  • Write and review technical documentation (development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing)
  • Creation, execution of Validation Protocols (system qualifications and process performance qualification), including identification and resolution of non-conformances/deviations.
  • Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections.
  • Manage contractors performing system qualifications, ensure the quality of completed deliverables.
  • Report status and progress of qualification activities or projects to the Leadership team.


Knowledge & Skills
  • Demonstrated knowledge of pharmaceutical primary and secondary packaging line equipment, labeling formats and requirements, and associated qualification practices.
  • Demonstrated knowledge of Systech vision system qualification, and serialization/aggregation functionality and requirements.
  • Demonstrate the ability to translate system requirement specifications into executable validation protocols.
  • Demonstrated knowledge of pharmaceutical manufacturing of pharmaceutical products, aseptic processing, and process development.
  • Able to read and interpret drawings such as blueprints, PFDs, P&IDs. Ability to read PLC logic is a plus.
  • Experiences with various manufacturing systems (including formulation systems, SIP, CIP) that are integrated with PCS and eProcedure.


Education & Experience
  • A Bachelor's Degree in Science, Engineering or a related field with a minimum of seven (7) years of experience.
  • Knowledge of the validation role inside of a cGMP manufacturing environment.
  • Experience working with the regulations and requirements for biologics or pharmaceuticals.
  • 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.
  • Equipment and System qualification experience in a cGMP environment for process equipment, manufacturing systems, and packaging operations.
  • Process performance qualification (new and modified processes) experience in a cGMP environment.
  • Experience with computerized systems lifecycle management with data integrity requirements.
  • Experience with manufacturing equipment that are integrated with site Process Control System (PCS).


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.\u200b

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.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---La-Verne/Senior-Validation-Engineer-I_R0021236





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