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
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.