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Form of workUnited 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. Gilead’s 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 company’s five core values. That’s 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
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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
Under the supervision of the Maintenance Manager (Calibration), the Maintenance Specialist (Calibration) will support the team by defining customer/process requirements, primarily, on instruments and equipment used across Gilead SD/LV sites, improving reliability for all instruments supported by the Outside Vendor Calibration Services (OCS).
Specific Job Responsibilities:
- Manage Outside Calibration Services (OCS) Team.
- Communicate with multiple calibration service providers to arrange calibration of customer instruments as well as Metrology Standards.
- Maintain PO's, acquire RMA's, track shipping and receiving of all instruments under OCS program.
- Provide Key Performance Indicators of OCS Program to management.
- Provide feedback and implement process improvements to improve compliance, customer experience or efficiency.
- Procures spare parts, special equipment, contracts, documentation and equipment availability for work execution.
- Schedules windows of availability with service providers, in conjunction with area owners, to minimize downtime.
- Acts as a mentor to junior staff with some task management responsibility.
- May act as project lead within the function.
- Exercises judgement within well defined and established practices and policies in selecting methods and techniques for obtaining solutions.
- Analyze and approve calibration ranges/tolerances.
- Work with customers to recommend new/replacement instruments based on use, principle of operation, etc.
- CAPA and Change Management ownership, implementation, tracking.
- Understands basic uncertainty contributor and standard deviation calculations.
- Lead and/or participate in reliability assessments (FMEA, RCFA, etc)
- Review and approve calibration technician work, provide work order review/closure in a timely manner to ensure continued compliance.
- Open/Investigate Deviations and Out of Tolerance events, including Metrology related impact assessments, as needed.
- Revise calibration job plans, data sheets and SOP's, as needed.
- Strict adherence to Standard Operating Procedures, safety requirements, training requirements and cGMPs.
- Identify waste, workflow interrupters, safety, training and other opportunities for improvement, recommend solutions, and assisting with implementation.
- Identifies and utilizes appropriate procedures. Generates certificates of calibration and/or out of tolerance reports as required and in correct media appropriate to meet customer requirements.
- Perform planning/scheduling for routine and on-demand calibrations/repairs.
- Troubleshoot, repair and assist in calibration of instruments and equipment.
- Ensure activities are accomplished in a safe manner and with quality mindset.
- With guidance, works on the resolution of instrumentation issues with limited direct supervision.
- Ensure work is appropriately communicated to system operators and key stakeholders.
- Ensure work order documentation is completed accurately and completely.
- Review and approve calibration work orders to ensure work is performed to SOP requirements.
- Train technicians, as needed, to ensure department maintains high level of training readiness.
- Assists in maintaining laboratory and performs other duties as assigned.
- May perform other duties as assigned/requested.
Knowledge & Skills:
- Demonstrate a working knowledge of process engineering systems, methods and procedures.
- Develops solutions to routine and/or complex problems.
- Requires understanding and application of Metrology/Instrumentation principles, concepts, practices and standards.
- Able to work independently or in a team environment.
- Able to write reports and correspondence.
- Able to respond to common inquiries from customers, co-workers, and/or management.
- Able to effectively present information to an internal department and/or large groups.
- Proficient in the use of CMMS and Windows based applications.
- Able to read and understand wiring diagrams, piping and instrumentation diagrams, etc.
- Able to comprehend and interpret instructions, short correspondence, and memos and ask clarifying questions to ensure understanding.
Required Education & Experience:
- 5+ years of relevant experience and a BS in Engineering OR
- 3+ years of relevant experience and a MA or MBA.
- Knowledge of cGMP manufacturing.
- Strong computer skills, CMMS Blue Mountain and Maximo experience.
Preferred Experience:
- Previous experience in engineering in highly regulated manufacturing environments desirable.
- Previous experience in biotech or pharmaceuticals industry desirable.
- Experience analyzing instrument/loop specifications and identifying practical calibration tolerances using statistical tolerance analysis methods.
- Experience in instrumentation and control, installing, calibrating, maintaining, and repairing equipment/process loops.
- Precision Measurement Equipment Laboratory (PMEL) experience.
- Understanding of control systems and PLC logic
The salary range for this position is: $97,495.00 - $126,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 ApplicantAccommodations@gilead.com 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.
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