CSV Engineer

CSV Engineer – USA, Seattle – 18 Month Contract

Our client, a global biotechnology organization, 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.

• 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 Analyzers, Liquid Handlers, etc.)
• Qualification of manufacturing automation systems (e.g. Delta
  
  V, MES, etc.)

• 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!