Validation Engineer II
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Job Location:
La Verne, CA - USA
Monthly Salary:
$ 99705 - 129030
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
Key Responsibilities
- Contribute to validation projects by developing schedules master plans impact assessments risk assessments validation protocols reports and requirements trace matrices for complex systems supporting clinical and commercial manufacturing.
- Perform Computer System Validation (CSV) elements for equipment utility systems facilities processes and automation systems.
- Author validation master plans risk assessment documents protocols technical reports and requirement trace matrices.
- Embed data integrity principles into daily operations and validation programs.
- Coordinate validation activities with cross-functional teams to ensure timely and budget-conscious execution.
- Foster collaborative relationships across teams to deliver high-performance validation programs.
- Identify and drive continuous improvement initiatives for compliant and lean sustainable solutions.
- Review project-related documents and data from vendors validation teams and project teams.
- Represent the validation department on cross-functional project teams.
Basic Qualifications
- Bachelors degree in science or a related field with 4 years of relevant experience OR
- Masters degree (MS or MBA) with 2 years of relevant experience.
- Understanding and application of validation principles including GAMP Part 11 Data Integrity and Annex 11.
- Proficiency in current Good Manufacturing Practices (GMPs).
- Working knowledge of equipment systems and industry practices.
- Strong verbal technical writing and interpersonal communication skills.
- Ability to resolve moderately complex validation issues with limited supervision.
- Proficiency in Microsoft Office applications.
Preferred Qualifications
- Experience using Root Cause Analysis tools.
- Operational excellence mindset and experience driving continuous improvement initiatives.
- Experience coordinating cross-functional validation projects.
For additional benefits information visit:
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights 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 apply via the Internal Career Opportunities portal in Workday.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
