Jul 14, 2019

Validation Engineer : 19-02323

  • Akraya Inc.
  • Sunnyvale, CA, USA

Job Description

Akraya is looking for a Validation Engineer for one of our leading clients. To be considered, please apply or call Moiz at 408-816-2442.
We are an award-winning staffing firm that works with many leading technology-based companies around the world. The benefits offered to our employees include Health Insurance (Medical, Dental, and Vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws). If this position is not quite what you’re looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better match at one of our many amazing clients.
Primary Skills: Software Validation experience, quality documentation, medical device
Duration: 3+ Months (possible extension)
Tax Term : W2 Only  

Primary Function of Position:
  • Responsible for validating quality systems software applications to meet internal procedures and external regulatory requirements.
  • Write high quality technical documentation to ensure validation documentation are audit ready.
  • Work closely with cross-functional teams to document validation deliverables throughout the software development life cycle and during software maintenance phase.
  • Bachelor’s Degree in engineering, technical writing or other technical areas preferred.
  • A minimum 6-year’s work experience with validation focus within the Medical Device and/or Pharmaceutical Industries is preferred.
  • History of working effectively and collaboratively within cross-functional teams is very desirable.
  • Strong technical writing abilities is required with the ability to translate complex technical information into clear concise understandable language.
  • Strong attention to detail to minimize documentation errors is required.
  • In-depth understanding of software validations to validate quality systems software applications is preferred.
  • Skilled in the use of Microsoft Office Suite, Agile/ACCS, and Client-ALM.
  • Experience and working knowledge with Medical Device regulations ISO 13485:2016, 21 CFR 820, 21 CFR Part 11, FDA’s General Principals of Software Validation, and best practice TIR36/GAMP5.
  • Experience with enterprise data warehouse, web applications, mobile applications, and data analytics reporting tools a plus.
  • Experience with cybersecurity and networking a plus.
     Please apply directly with your update resume or call Moiz at 408-816-2442

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