Computer System Validation Engineer

Job Title: The ideal candidate will be responsible for ensuring GxP compliance, data integrity, and adherence to Computer Software Assurance (CSA) principles throughout the validation lifecycle. Responsibilities: Lead validation planning, risk assessment, and execution for statistical programming environments, source code management systems, and Clinical...

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols...

Job Title: IT Validation Services SpecialistDescription:We are seeking a skilled IT validation services specialist to join our team. The ideal candidate will have a strong background in computer system validation, change management and systems development life cycle methodologies.Responsibilities:

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/ HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: ...

Job DescriptionWe are seeking a seasoned professional to lead our validation team in a strategic, risk-based approach. This individual will be responsible for optimizing legacy computer system documentation and ensuring compliance with all project requirements.The ideal candidate will have expertise in computer system validation, good documentation...

The position of Senior Manufacturing Systems Expert is a critical role in our organization. The ideal candidate will be responsible for leading a team of internal and external professionals, geographically dispersed, to design and implement new manufacturing systems.The successful candidate will have extensive experience in regulated manufacturing,...

Job Summary">The Manufacturing Systems Engineer will be responsible for overseeing the development and implementation of innovative manufacturing solutions. They will work closely with cross-functional teams to design, implement, and maintain complex manufacturing systems.Key Responsibilities:Develop and implement strategic plans for manufacturing process...

Responsibilities: Design, configure, and program within Labware LIMS Version and Bio via One Lab to meet business and laboratory requirements. Develop and maintain Crystal Reports for operational and analytical reporting. Implement and manage laboratory instrument and external system integrations using both file-based and API-based methods. Collaborate...

Job Description: Quality Engineer II is responsible for ensuring that products and processes meet established quality standards and customer requirements. This role supports the development, implementation, and maintenance of quality systems in accordance with industry regulations and company standards. The QE II will take an active role in root cause...

Responsibilities: Customer case handling – End customers and as well as Internal Customers. Provides support, leadership and guidance during Customer escalations and emergencies, keeping customer Service Level Agreements (SLAs) in mind. Analyses and finds root causes of product issues, by understanding logs, metrics, pcap files and customer...