Danaher Corporation Computer Systems Validation Specialist in Sunnyvale, California
At Cepheid, 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. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).Position summary:This role, as an Individual contributor, is recognized as our organization’s expert for computer systems validations throughout Cepheid. Guides the successful completion of complex computer system projects and often takes on a project leadership role. Applies extensive knowledge of technical principles in defining the validation strategy. Conducts gap analysis for 21 CFR Part11 guidance to software requirements.
ESSENTIAL JOB RESPONSIBILITIES:
Perform duties as an individual contributor and/or team member with 100% hands-on work
Define test architecture and strategy for complex and integrated systems
Coordinate and Participate in requirements development, configuration and change control, and Go/No-Go decisions.
Ability to update and author SOP
Write validation plans and reports
Create and Execute OQ and PQ protocols as needed
Guide users on validation of Macros/ Worksheets and aid in documenting them appropriately in the Inventory log.
Guide project team to write quality documents related to software validation and reviews for effectiveness
Guide project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
Define validation schedule, engage stakeholders to seek agreement on deliverables and responsibilities
Coordinate and conduct risk analysis
Create change orders in document control system
Review and approve change controls and other quality documents required to maintain the system in validated state
Participate in software supplier audits as needed
Maintains Non-product software inventory throughout the company
Participate in internal and external audits as a subject matter expert for computer systems
Education and Experience (in years):
- BA/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field with a minimum 2 years of software testing experience in a regulated environment
Knowledge and skills:
Must have completed several major computer systems projects (such as ERP, MES) with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field
Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks
Experience in leading resolution efforts when issues are identified and escalate appropriately
Experience in proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant
Must have experience with: Windows environments, Excel Macros/Worksheets, and SQL or other RDBMS systems
Ability to provide key inputs to Design Input Requirements of complex manufacturing lines
Update Traceability matrices and quality metrics
Be knowledgeable in QSR and 21 CFR Part 11 regulations
Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly
Able to lead small projects with manageable risks and resource requirements
Have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction
Experience with other applications such as defect tracking, web-based applications, requirements management
Experience working in a fast-paced environment while successfully working on multiple products simultaneously
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can 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, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Equal Opportunity Employer
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
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 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 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid