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The CSV Engineer will develop and execute validation protocols/documents, manage change controls, participate in audits, troubleshoot issues, assess compliance of systems, and coordinate with departments or contractors to maintain regulatory adherence in computer validation processes.
The Senior CQV Engineer at CAI is responsible for developing documentation related to commissioning, qualification, and validation of pharmaceutical facilities. This role includes protocol writing and execution, field verification, and overseeing small teams for project coordination at client sites. The Engineer will ensure compliance with FDA regulations and provide leadership in cGMP practices while actively participating in troubleshooting and problem-solving.
The Project Manager will lead cGMP initiatives, managing mid-sized to large projects in the Life Sciences sector, focusing on commissioning and validation activities. Responsibilities include oversight of CQV services, document management, progress tracking, and resource allocation to ensure project deliverables are met efficiently.
The Program Manager leads the Digital Enablement program, acting as a liaison between Professional Services and development teams. Responsibilities include managing communication strategies, overseeing project lifecycles, advocating for digital initiatives, and establishing performance metrics for program success.
The CQV Senior Project Manager leads the execution of CQV projects for life sciences clients, ensuring operational readiness. Responsibilities include managing project lifecycle, risk analysis, stakeholder engagement, and communicating budget impacts due to scope changes.
The Senior CSV Engineer is responsible for validating and qualifying computer systems in compliance with regulatory standards. This includes preparing and reviewing validation documentation, managing change controls, analyzing testing results, troubleshooting issues, coordinating between departments, and participating in regulatory audits.
The CSV Engineer will develop and execute protocols and test scripts, consult on resolutions, and write documentation related to GxP computer validation and 21 CFR Part 11. Requires collaboration with industry experts to ensure compliance in the biotech and pharmaceutical sectors.
The CQV Engineer will develop documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities and equipment. Key responsibilities include protocol writing and execution, field verification, and summarizing reports at client sites. The role requires strong problem-solving skills and experience in FDA regulated industries.
As a Project Manager at CAI, you will lead the integration and delivery of commissioning and validation services for Life Sciences clients. Responsibilities include managing mid-sized to large projects, overseeing project resources, and ensuring compliance with cGMP standards. You will also provide guidance for documentation related to regulatory requirements and collaborate with internal and external stakeholders to track project progress.
The CQV Engineer will develop documentation for commissioning, qualifications, and validations, focusing on the pharmaceutical industry. Responsibilities include protocol writing, execution of field verifications, and the creation of summary reports at client sites. The role demands excellent problem-solving skills, attention to detail, and the ability to manage the C&Q documentation lifecycle.
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