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Software Validation Analyst - GxP at Egnyte

Software Validation Analyst - GxP

Egnyte Raleigh, NC (Onsite) Full-Time

We’re currently on the lookout for a Software Validation Analyst to join our GxP Quality Assurance team at Egnyte!

Egnyte’s secure content services platform serves several hundred life science companies and tens-of-thousands of users in the life sciences industry.  Biopharma, medical devices, and CRO/CDMOs rely on us to manage regulated data, collaborate internally and externally, and protect their data. Given the industry’s intense focus on software validation, compliance, and security, we need to ensure that our products meet the strictest GxP compliance standards.

The Software Validation Analyst will lead User Acceptance (UA)/Performance Qualification (PQ) validation projects for Egnyte GxP customers.  The individual serving in this role will have responsibility for using their validation expertise and knowledge to work with customers on gathering their user requirements and conducting validation activities on their Egnyte domain.

If you are passionate about computer system validation and GxP compliance, Egnyte could be a perfect match for you.

What You’ll Do (but is not limited)

  • Consultation with customer to develop User Requirements for their intended use of Egnyte software
  • Develop User Acceptance (UA)/Performance Qualification (PQ) plans
  • Design and develop UA/PQ test scripts
  • Execute UA/PQ testing along with working with internal teams and/or customer for issue resolution
  • Issue status reports of validation progress and summarize UA/PQ validation results
  • Produce high quality UA/PQ validation documentation deliverables
  • Act as liaison between customers and internal teams such as Sales, Engineering, Product Management and Technical Support to solve technical problems and propose new feature development
  • Follow applicable Egnyte Quality System procedures (e.g., Polices, SOPs, Work Instructions) to ensure successful completion and delivery of UA/PQ validation projects
Your Qualifications
  • Minimum of 3 years of experience in conducting the complete UA/PQ validation phase for software used in a GxP environment
  • BS degree in Computer Science or related field, or equivalent combination of education and experience
  • Experience with Life Science regulations, such as 21 CFR Part 11, Annex 11, GDPR
  • Understanding of electronic signatures and signing sessions
  • Understanding of ALCOA principles and how they relate to software validation
  • Good knowledge of Life Science industry best practices for validating software such as GAMP (V-model) and PIC/S
  • Experience with Agile software development life cycle (SDLC) methodologies
  • Experience with software testing methodologies
  • Solid communication skills (verbal and written) that allow you to effectively work with internal team members and Egnyte customers
  • Expert ability with productivity tools such as: MS Word, Adobe, DocuSign, MS Excel, Google application suite
  • Ability to multi-task and manage multiple projects with strict deadlines
  • Good ability to communicate professionally and succinctly, verbally and in writing

Our Benefits

  • Competitive salaries, comprehensive benefits & pre–IPO stock options
  • Flexible hours, generous time off (RTO, Responsible Time Off) to help support your work-life balance
  • Full offering of paid holidays and sick time
  • Paid family leave to help you grow your family (12 weeks for birth parent, 10 weeks for non-birth parent, 10 weeks for adoption)
  • Gym, cell phone, internet and commute reimbursement
  • 401(k) Retirement Plan (Traditional and Roth)
  • Health Savings Account (HSA), Flexible Spending Account (FSA) and Employee Assistance Program (EAP)
  • Wellbeing programs to help you feel healthy and balanced including memberships to Aaptiv, Ginger, Headspace and more
  • Perks including discounted pet insurance, electronics, theme park tickets, travel, and more
  • SoFi online financial services: student loan refinancing, personal loans, and investing
  • Free personal Egnyte account for life
  • Our compensation reflects the cost of labor across multiple U.S. geographic locations, and pay varies based on defined markets. The standard base pay range for this position across the U.S. is $40k - $90k annually. Pay varies by work location and may also be dependent on job-related skills, knowledge, and/or experience. During the interview and/or hiring process, your recruiter can share more information about the compensation package specific to the role and job location.

Equal Opportunity Employment

At Egnyte, we celebrate our differences and thrive on our diversity for the benefit of our employees, our products, our customers, our investors, and our communities. Employment at Egnyte is based solely on a person’s merit and qualifications directly related to professional competence. We do not discriminate based on race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity or expression, disability, age, veteran status, marital status, pregnancy or related condition, or any other basis protected by law.

About Egnyte

Egnyte provides a unified content security and governance solution for collaboration, data security, compliance, and threat detection for multicloud businesses. More than 17,000 organizations trust Egnyte to reduce risks and IT complexity, prevent ransomware and IP theft, and boost employee productivity on any app, any cloud, anywhere. Investors include GV (formerly Google Ventures), Kleiner Perkins, Caufield & Byers and Goldman Sachs.

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