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Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices.
Responsibilities:
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Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
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Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
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Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
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Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
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Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
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Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
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Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
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Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
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Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
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Qualification of laboratory analytical instruments (e.g. Cell Viability Analysers, Liquid Handlers etc.)
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Qualification of manufacturing automation systems (e.g. DeltaV, MES etc.)
Requirements:
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Bachelor's degree in Computer Science, Engineering, or a related field.
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Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
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Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
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Familiarity with validation methodologies, including risk-based validation approaches.
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Proficiency in creating and executing validation protocols and documenting validation activities.
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Excellent analytical and problem-solving skills, with attention to detail.
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Knowledge of software development life cycle (SDLC) and change control processes.
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Understanding of data integrity principles and practices.
For further information please contact Mick on (phone number removed) or forward details in confidence to
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