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Business Analyst – LIMS System Validation

Foster City, CA
Job Title:  Business Analyst – LIMS System Validation
Location:  Foster City, California
Job Type:  Long-Term Contract
 
Overview
 
We are looking for a Business Analyst – LIMS System Validation. This position will be responsible for defining Laboratory Informatics Systems (LIMS) validation requirements, developing LIMS systems validation documentation, generating and executing test protocols and summarizing validation activities in reports. The Business Analyst will play a key role throughout the system development life cycle (SDLC), from validation of complete new systems on projects through qualification of changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of the Pharmaceutical and Biotechnology industry.
 
Responsibilities 
  • Assists in the management of computer systems validation
  • Assists in defining validation strategy
  • Generation of validation documentation, which includes validation plans, audit plans, requirement specifications, test plans, IQ, OQ and PQ protocols, test cases/scripts, traceability matrices and validation reports
  • Development and execution of functional testing, both manual and automated
  • Conducting risk assessments and periodic audits of systems and software development activities
  • Ensures all systems and software are in compliance with GMP, GLP, GCP, QSR, 21 CFR Part 11, ICH guidelines, and GAMP guidelines
  • Assists in the management of controlled documents
  • Responsible for training related to validation projects, client-specific software applications and SOPs
  • Development of SOPs in support of quality systems and software development
 Requirements
  • Prior validation experience working with Laboratory Informatics Systems, e.g. Labware
  • Strong theoretical knowledge of Computer System Validation
  • BS in Computer Science, Laboratory Science (e.g., Biology, Chemistry, Biochemistry etc.), and/or Engineering
  • 3+ years of validation experience in the biotechnology, pharmaceutical or clinical
  • Working knowledge of GMP, GLP, GCP, QSR, GAMP and 21 CFR Part 11 as they relate to computer systems validation
  • Knowledgeable in applying SOPs, work instructions and regulatory requirements to the System Development Life Cycle
  • Experience with testing and supporting manufacturing, laboratory and clinical applications as well as business systems is helpful. (i.e. SaaS cloud, LES, MES, PLC, SCADA, LIMS, CDAS, CDMS, EDC, CTMS, SAP)
  • Experience with client server, RDMS databases (Oracle, SQL, etc.), and web applications
  • Excellent written and verbal communication skills
  • Ability to work as a supportive team member in a large scale project
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