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Validation Engineer II - La Verne, United States - Gilead Sciences
Description
For Current Gilead Employees and Contractors:For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.
At Gilead, we're creating a healthier world for all people.
For more than 35 years, we've 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 world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's 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 we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.Job Description
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.
Develop procedures and/or protocols.
Coordinates contract personnel through completion of assignments.
Works on cross-functional project teams 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.
Requirements:
4+ years of relevant experience and bachelor's degree in engineering or physical science or related field.
2+ years of relevant experience and an MS.
Understanding and application of validation principles, concepts, practices, and standards.
Working knowledge of current Good Manufacturing Practices (GMPs).
Experience with qualification of aseptic processing equipment primarily Isolator, Filler, Lyophilizer and Tank SIP, Dry Heat (Depyrogenation Tunnel) and Moist Heat Sterilization (Autoclaves), general temperature mapping.
Working knowledge of industry practices.
Good verbal, written, and interpersonal communication skills are required.
Investigation skills.
Proficient in Microsoft Office applications.
Be able to read and interpret drawings such as blueprints, PFDs, P&IDs.
The salary range for this position is: $97, $126, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit:
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.
for assistance.
For more information about equal employment opportunity protections, please view the
'Know 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 log onto your Internal Career Site
to apply for this job.
Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.#J-18808-Ljbffr