Validation Engineer : 19-01716

Sunnyvale, CA 94086

Posted: 04/15/2019 Job Category: Clinical Affairs Job Number: 12086320
        Women Back to Work (WBW)  candidates will also be considered for this position.

Akraya is looking for a “ Validation Engineer"  for one of our clients. If the job description below is a fit, please apply directly or call Moiz  at 408-816-2442.  If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many 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.
 
Skills/Experience
  • 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

About Akraya
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

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