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.
  • 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.

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.