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Engineer 2

Novato, CA 94949

Posted: 10/30/2023 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11466 Pay Rate: $65.00 - $69.00

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

  • Provide CSQA expertise and oversight of QC/BAS 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 across the Company.
  • Provide quality oversight to support and follow the Company's Data Integrity Program.
  • Establish and sustain the Company's 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 the Company.
  • 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.
  • Administer applicable electronic systems.
  • Assist as needed in audits and inspections.
  • 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.

Job Requirements

  • 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.

  • BS in a Computer Science or Engineering field or equivalent experience.

Meet Your Recruiter

Lexie Pierce

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.


Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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