System Validation Specialist (Contract, South San Francisco, CA)

Description:

Genentech is looking for a Validation Specialist in South San Francisco, CA. It is a 6+ months contract on W2. 

 

Biotech/Pharma exp REQUIRED



Please email your Resume attached as a Word Doc along with your desired Hourly Rate, your current location, visa status and date you are available to start a new position. Please make certain your resume clearly details your experience with the skills required for this requirement.

Also please provide a brief writeup about why you are a match for the position that can be passed along to the manager. If you have worked at Roche or Genentech in the past please provide your previous managers names, so they too can be passed along to the hiring manager.

Duties:

  • Collaborate with Project Managers, Architects, Engineers, Developers, and User Experience Designers on business systems scope, solutions, constraints, and risks.
  • Analyze business scenarios that may potentially be solved by implementation of automated systems and/or modifications to business processes.
  • Provide expertise in identification, evaluation, design, development, and deployment of business systems and/or processes.
  • Participate in delivery of solutions that are cost effective, sustainable, and meet business requirements.
  • Accountable for documentation, which may include, but is not limited to user requirements, functional and/or technical specifications, process flow diagrams, training documentation and/or work instructions, and Computer System Validation documents.
  • May configure system settings and/or options.
  • Provide consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions – both systems and processes.
  • Facilitate and/or support customers in UAT (user acceptance testing) planning and execution.
  • Participate in and advise roadmap discussions.
  • Drive resolution of business or systems issues.
  • Utilize knowledge of application development methodologies, such as Agile, to drive process modeling and re-engineering.

 

Skills: 5 years of experience with:

  • Computer systems validation, including CSV processes and deliverables
  • 21 CFR Part 11 regulations
  • Gathering of requirements for IT solutions
  • Technical documentation, including IT system risk assessments
  • Full software development lifecycle
  • Good Manufacturing Practices in a biotech or pharmaceutical related regulated manufacturing environment
  • 1+ years of experience with agile project management methodology

 

Education:

  • BA/BS in Business, Science, or Computer Science preferred

 

Required Skills: 

  • BSA 

Skills:

Please review all application instructions before applying.

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