Validation Engineer II - Irvine, CA

Provide technical expertise and guidance for the preparation and execution of validation protocols and reports. Review and troubleshoot anomalies, deviations, etc. Resolves and consults on applicable validation compliance and manufacturing process issues. Mentor and leads projects. Provide technical reviews of protocols. Contribute at the validation project team level for validation activities.

https://www.indeed.com/viewjob?t=validation+engineer+ii&jk=c1032a22948a00e2&_ga=2.54114408.1395148856.1545000919-2077807285.1533320279

Computer System Validation - Morrisville, PA

Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, and other applicable regulations or procedures. Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.

https://www.indeed.com/viewjob?t=computer+system+validation&jk=2caf07db91cfb007&_ga=2.175767522.1395148856.1545000919-2077807285.1533320279

Sr. Biostatistician - Alapocas, DE

Interact with members of the multidisciplinary project teams to establish project timelines.Provide statistical input to study protocols. Write statistical analysis plans.Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.

https://www.indeed.com/viewjob?t=sr+biostatistician&jk=74cfc33729eaf688&_ga=2.209321810.1395148856.1545000919-2077807285.1533320279

Computer System Validation - Morrisville, PA

Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, and other applicable regulations or procedures.Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.

https://www.indeed.com/viewjob?t=computer+system+validation&jk=2caf07db91cfb007&_ga=2.7057650.1395148856.1545000919-2077807285.1533320279

Sr. Validation Lead, DI - San Mateo, CA

Computer System Validation processes expert.Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

https://www.indeed.com/viewjob?t=sr+validation+lead+di&jk=36529ff94862bef4&_ga=2.246010052.1395148856.1545000919-2077807285.1533320279

Product Development-Validation - Draper, UT

Participating in Internal audits, QMS audit, customer audit and reporting the audit findings to management. Identifying Gaps and Coordinate with stake holders for CAPA preparation and implementationQualification: Ensuring all jigs and fixtures, process parameters are qualifiedHandling Corrective and Preventive Actions, Customer Complaints, and responsible for Defect-free Product deliveries to the Customer.Prepare deliverables and track each activity till closure

https://www.indeed.com/viewjob?t=product+development+validation&jk=f91783282452586b&_ga=2.221810904.1395148856.1545000919-2077807285.1533320279

Product Development-Validation - Draper, UT

Participating in Internal audits, QMS audit, customer audit and reporting the audit findings to management. Identifying Gaps and Coordinate with stake holders for CAPA preparation and implementationQualification: Ensuring all jigs and fixtures, process parameters are qualifiedHandling Corrective and Preventive Actions, Customer Complaints, and responsible for Defect-free Product deliveries to the Customer.Prepare deliverables and track each activity till closureWork closely with Program manager and update status on daily basisWrite or review procedures and related documents

https://www.indeed.com/viewjob?t=product+development+validation&jk=f91783282452586b&_ga=2.11702388.1395148856.1545000919-2077807285.1533320279