CSV Engineer
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- Job type
- Contract
- Location
- Seattle, Washington, United States
- Ref. No
- 37812
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:
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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.)
- 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.
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- Caroline O`Sullivan
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