Overview
PE Global is currently recruiting for a CSV Engineer for a leading multi-national Biotech client based in Dublin. This is an initial 12-month contract position.
Base pay range
Direct message the job poster from PE Global
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 manufacturing automation systems (i.e DeltaV, MES etc.).
Qualifications
* 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.
* 5+ years 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.
* Experience on sterile drug product manufacturing and associated equipment/utilities/laboratory instruments/IT infrastructure and enterprise systems.
* Experienced in computer systems validation (CSV) from requirements to through release of SCADA/PLC controlled equipment (e.g., filling lines, isolators, Lyophilisers).
* Experienced in computer systems validation (CSV) of Emerson DeltaV.
* Completion of Electronic Records and Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
* Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.
Seniority level
* Mid-Senior level
Employment type
* Contract
Industries
* Pharmaceutical Manufacturing
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