Senior Validation Engineer
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POST DATE 8/9/2016
END DATE 1/13/2017
Gilead Sciences, Inc
San Dimas, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
Reviews protocols, reports and data tables generated by peers and contract personnel.
Represents the department on cross-functional project teams.
As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.
KNOWLEDGE, EXPERIENCE AND SKILLS
In-depth understanding and application of validation principles, concepts, practices, and standards.
Proficient in current Good Manufacturing Practices (GMPs).
Extensive working knowledge of equipment and systems.
Extensive knowledge of industry practices.
Excellent verbal, written, and interpersonal communication skills are required.
Demonstrated investigation and report writing skills.
Proficient in Microsoft Office applications.
7+ years of relevant experience and bachelor s degree in science or related field.
5+ years of relevant experience and a MS or MBA.
3+ years of relevant experience and a PhD.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 email@example.com for assistance.
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