CSV/Validation Engineer - Pharma Domain

Posted on Oct 18, 2020 by eTeam Inc.

Cork, Ireland
Immediate Start
Annual Salary

Job Title: CSV/Validation Engineer - Pharma Domain
Location: Brinny, Ireland
Type: Contract role

Main Skills:

  • CSV experience in pharma domain
  • GxP exp is mandate
  • Data Integrity
  • SDLC

Detailed Description:

  • 5 years of Lab Systems validation experience is required.
  • Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
  • Understanding of Data Integrity concepts is required
  • Excellent communication and written skills required

Job Responsibilities:

  • Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
  • Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
  • Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
  • Coordinate alignment of systems users from various company groups on validation and qualification documentation
  • Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
  • Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
  • Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.

Reference: 975708419

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