Yoh is seeking a Quality Software Engineer to lead the validation of our client's proprietary Clinical Trial software in a semi-remote position. As the SME, you will be working in a fast moving environment to ensure the platform follows strict CFR compliance and protects user data. This role is an ideal fit for individuals with 5 or more years' experience in an IC role focused on the validation of pharmaceutical technology. A Bachelor's degree Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field is preferred.

Hours: M-F 8-5pm

Industry: Pharmaceutical software

Location: Remote, New York, NY - will need to travel as required

Type: Direct hire, full-time

Responsibilities

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  Function as SME approving/authorizing key documents such as User Requirements Specifications, Validation Plan, Risk Assessment, Test Protocols/Reports, Validation Summary Report, and releasing systems into production

  
  


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  Direct the validation of proprietary clinical trial software

  
  


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  Perform system audits to ensure clinical data protection meets strict regulatory standards according to (CFR) 21 Part 11 Compliance

  
  


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  Lead Audit Preparation and Support, Data Migration, and Release and Change Management Process

  
  


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  Drive the planning, implementation, administration and communication of data privacy across the org

  
  


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  Conduct the collection, use, transfer, storage and deletion of personal information

  
  

Qualifications

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  B.S. in Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field

  
  


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  5+ years' experience in software validation for pharmaceutical platforms

  
  


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  Thorough understanding of GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements and good documentation practices

  
  


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  Lead and manage high level projects

  
  


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  Proven verbal and written communication skills

  
  

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Visit https://www.yoh.com/applicants-with-disabilities if you are an individual with a disability and require accommodation in the application process.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.