CSV Consultant, Laboratory Systems

Location: San Diego Consulting
Department: Azzur San Diego, LLC

Job Description

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Lead qualification efforts for Laboratory Instruments and associated computer systems
  • Perform Data Integrity gap assessments and implement remediation plans.
  • Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
  • Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
  • Perform testing of the entire SDLC, including version/change control and new software rollouts.
  • Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
  • Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
  • Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).

Qualifications

  • BS in Engineering, Science or equivalent technical degree.
  • 8+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in independently performing laboratory computer system validation throughout the lifecycle
  • Experience in independently leading data integrity assessments
  • Experience in developing lifecycle documentation for computer systems (e.g. requirements specifications, risk assessments, plans, traceability matrix, protocols, reports)
  • Experience in executing validation documents for computer systems
  • Experience with project management
  • Strong knowledge of FDA and cGMP regulations and documentation practices
  • Strong knowledge of GAMP 5
  • Strong knowledge of 21 CFR Part 11 and Annex 11
  • Strong knowledge of computer system validation methodologies
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint

​Preferred Qualifications

  • Master of Science in Engineering, Science or equivalent
  • Validation of manufacturing control systems
  • Validation of building automation/management systems
  • implementation and Validation of EDMS and QMS
  • Implementation and Validation of laboratory software systems (e.g. LIMS, Empower)
  • Implementation and Validation of cloud based system
  • Network infrastructure
  • IEC 62304, ISO13485 regulated Quality system
  • Medical device software V&V (embedded software)

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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