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Are you an experienced CSV professional ready to take on a critical role in a highly regulated and innovative environment? Our client, a leading organization in the pharmaceutical and biotechnology sector, is seeking a Computer System Validation (CSV) Specialist to support and lead validation activities across manufacturing, laboratory, and enterprise systems.
If you're a detail-oriented problem solver with a strong background in regulated environments and a passion for ensuring data integrity and compliance, we’d love to hear from you.
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.)
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.
* 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. 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.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
IT Services and IT Consulting
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