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CSV Engineer

  1. North America, East Coast
Seattle
  1. Contract
Competitive
  1. Life Sciences
37812
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CSV Engineer - USA, Seattle - 18 Month Contract

Our client, a global biotechnology organisation, is recruiting for a CSV Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Engineer to help expand our client's biotech operations throughout Europe. As the CSV Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.

Responsibilities:
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
  • Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
  • Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
  • Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
  • Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
  • Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
  • Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
  • Qualification of laboratory analytical instruments (e.g Cell Viability Analysers, Liquid Handlers etc.)
  • Qualification of manufacturing automation systems (e.g DeltaV, MES etc.)
Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.
  • Excellent analytical and problem-solving skills, with attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  • Ability to work independently and manage multiple projects simultaneously.
  • Knowledge of software development life cycle (SDLC) and change control processes.
  • Understanding of data integrity principles and practices.
If this role is of interest, apply now!

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