My client is seeking a highly skilled and experienced Computer System Validation (CSV) Engineer with a strong background in Laboratory Instrument Qualification. The successful candidate will be responsible for ensuring that all laboratory instruments and computer systems are validated and qualified in compliance with regulatory requirements and industry standards.
The role:
* 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.
Key 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.
* 5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
* Experience on Sterile Drug Product manufacturing and associated equipment / utilities / laboratory instruments / IT Infrastructure. enterprise systems.
* Experienced in computer systems validation (CSV) from requirements to through release of SCADA / PLC controlled equipment (i.e. filling lines, isolators, Lyophilisers)
* Experienced in computer systems validation (CSV) of Emerson DeltaV.
* Completion of Electronic Record 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.
The Next Step for you:
Should this position be of interest to you please submit your CV to
Barry O'Mahony
from Next Generation Recruitment using the apply button.
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