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Danaher Corporation Document and Change Management Specialist and PLM Trainer in Sunnyvale, California

Make an immediate impact on a global scale!

At Cepheid, leader in molecular diagnostics, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications.

The work we do every day will change patient care around the world! Be inspired knowing you’re part of the team helping to diagnose the most challenging diseases. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

This position is part of the Quality Systems Department and will be located in Sunnyvale, California.

In this role, you will have the opportunity to:

  • Develop training materials within an electronic Learning Management System and presents training related to information management project deliverables and use of the Oracle/Agile PLM system

  • Create, conduct, analyze and socialize results from electronic surveys and polls associated with process improvement ideas, new systems or deliverables associated with specific projects.

  • Assist with scheduling and leading project team meetings, maintaining and distributing meeting minutes, reporting project status updates and coordinating tasks.

  • Assist Document Control and the Oracle/Agile PLM Client Administrator with periodic audits of system content and to fulfill electronic Work-Ticket requests for maintenance of various databases, control matrices, attribute values and analytics in the Oracle/Agile PLM system and other information or content management systems, SharePoints, Microsoft Teams channels, Excel spreadsheets in corporate network intranet folders, etc. Review and execute computer and business system validation protocols and write resulting reports.

  • Assess the type of training materials (e.g. written procedures, quizzes, multimedia), create training materials and deliver instruction (via electronic Learning Management System or Instructor-Led Training) at a frequency and depth appropriate to ensure complex and on-going changes to Document Control or Change Management processes and systems are introduced to, and adequately understood by the target audiences and groups.

  • Collaborate cross-functionally with IT Global Business Services, Oracle/Agile PLM system client users and other business system managers and users to assess, develop and implement solutions to technical challenges, integrations, user-experience enhancements and quality continuous improvement deliverables associated with information management, access and control.

  • Participate in structured Kaizen events, Danaher Business System activities, Project Teams, global Change Management Team and local Document Control Team meetings to contribute ideas and insight for information management process and procedure changes to improve effectiveness and efficiency and to drive industry standard best practices.

The essential requirements of the job include:

  • Bachelor's degree with 2+ years of related work experience

  • Demonstrated solid understanding of Quality System Regulations (21 CFR Parts 11 and 820, FDA cGMP) and ISO requirements (13485-2016

  • Oracle/Agile 9.2/9.3 (or other similar PLM system) “power-user” or administrator experience

  • Experience with developing training materials/quizzes in an electronic Learning Management System such as UL ComplianceWire

  • Working knowledge of Windows Operating Systems (current

  • Experience in analyzing and compiling data to support metrics reporting and analyzing current processes.

It would be a plus if you also possess previous experience in:

  • Experience creating computer multimedia training (videos) and conducting on-site or remote Instructor-Led training (via Zoom, etc.).

  • Experience reviewing and executing validation protocols and reports in a Medical Device environment.

  • Experience in Product Lifecycle Management process definition, analysis, design and implementation.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, and results-oriented.

Danaher is committed to competitive compensation that typically has key components including base salary, and variable annual incentive compensation based on personal and company performance.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid