Job description
For Current Gilead Employees and Contractors:
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Job Description
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.
Senior Device Engineer I, Sustaining Engineering
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.
Qualified candidates will focus on lifecycle management of parenteral combination products (e.g., autoinjectors, needle safety devices, reconstitution kits, etc.) and serve as subject matter expert for commercial combination products. We are seeking a motivated, detail oriented individual able to contribute in a cross-functional team setting.
The position is site based role working from either the Foster City, CA or Cork, Ireland site.
Specific Job Responsibilities
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Represent Device Engineering in cross-functional teams managing commercialized combination products.
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Partner with QA and Operations to evaluate product complaints and identify root causes for complaint trends.
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Lead change control activities for post-market design changes of commercialized combination products.
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Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
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Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations as applicable.
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Support device product quality investigations, CAPAs and change control activities.
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Effectively communicate ideas, project goals, and results to team members across functions and departments.
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Qualified candidates should be self-motivated and organized, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Required Education, Experience & Skills
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A Bachelor’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and several years of relevant industry OR a Master’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a significant years of relevant industry.
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Experience with structured problem solving methodologies, such as root cause analysis.
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Experience leading combination product lifecycle management activities is desired.
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Strong verbal, written, and interpersonal communication skills are required.
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Must be able to write clear, concise, and error-free documents.
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Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
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Working knowledge of FDA and cGMP standards for combination products.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
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