Novato, CA

Engineer 2 Global QA CSA

Engineer II – Global QA CSA
Location: Novato, CA (On-Site
12-Month Assignment (potential to extend)
Pay: $65-68 / hour

Our client, a world leader bio-tech company who focuses on delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases, is looking for an Engineer II-Global QA CSA to join their team. 

  • Provide CSQA expertise and oversight of QC/Client Analytical Instrument, Enterprise, Operations/Supply Chain and Quality computerized system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
  • Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems and/or changes to existing validated computer systems.
  • Provide guidance and support root cause analysis on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
  • Apply Risk-based methodologies across the computerized system lifecycle.
  • Provide guidance and QA oversight for SDLC documents like User Requirements.
  • Specifications and Validation/Qualification protocols and test scripts.
  • Responsible for the authoring and development of Periodic Reviews Reports for computerized systems.
  • Establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
  • Partnering with internal and external IM, QA, and Development Sciences teams; sharing information to increase the collective understanding of QA and Data Integrity programs.
  • Knowledge of industry standards; 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at BioMarin.
  • Ensuring alignment of processes, procedures, and methods across multiple organizations (internal and external).
  • Authoring and /or revising SOPs.
  • Authoring and / or revising validation documents and protocols.
  • Contribute to projects related to CSQA improvements and system reliability.
  • Development, execution, and approval of change control records.
  • Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.

Education and Experience:

  • BS in Computer Science or Engineering field
  • 3 to 5 years' experience in CSV in the Life-science/regulated industry
  • 3 to 5 years working in the Quality area in biotech or pharma
  • Experience in Deviations, CAPAs and Change Control Management
  • Strong knowledge and implementation experience on industry regulations (e.g., 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance's (e.g., ISPE GAMP, MHRA)
  • Good knowledge and implementation experience on Data Integrity requirements (e.g., ALCOA & ALCOA+)
  • Experience with Computer Systems Periodic Reviews
  • Experience with Veeva QMS and Quality Docs
  • Experience with Office 365
  • Experience with SAP desirable
  • Experience with ALM desirable  

  • Max. file size: 300 MB.