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Validation Engineer 1 : 19-05052
Ref No.: 19-05052
Category: Quality Assurance and Testing
Location: Sunnyvale, California
Primary Skills: CRM, SAP, SFDC, ERP, Outlook, Word, Excel, ISO 13485, 21 CFR 820
Duration: Long Term
Contract Type: W2 Only


Description :
  • Prior responsibility for process, equipment or product validation/verification.
  • Train to Process Validation DOP 853174.
  • Ability to generate PPQ Protocol per template 853174-05P.
  • Ability to generate PPQ Report per template 853174-05R.
  • Ability to perform IQOQ (Installation Qualification / Operational Qualification) for EFTs as necessary.
  • Archive results/report in SAP.
  • Agile (ACCS) originator access and basic navigation skills.
  • Generate and release Engineering Change Orders.
  • SAP access and navigation skills.
  • Train to Quality Notification generation (MPI 859027).
  • Archive Equipment Event (EE) results/report in SAP.
  • Support Client/VR/EEs as necessary.
  • Ability to access and use a variety of computer software; proficiency in Microsoft Office software suite (Word/Excel/PowerPoint).
  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Primary work schedule is day shift, Monday Friday but must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include evenings, weekends and holidays, in order to meet project deadlines. Some travel, both domestic and international, may be required based on project needs.
  • Minimum of 2 years of experience in Process Validation and / or Process Engineering is required.
  • Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices is preferred.
  • Strong technical knowledge and experience with validation/qualification of manufacturing processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
      To follow up with any questions, please contact Vaibhav at 408-512-2355.

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including 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 fit at one of our many amazing clients.
 
Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.