Engineers are responsible for technical aspects of the design, delivery, and qualification/validation of the device assembly..., qualification/validation, and Computer System Validation: Automated Control Systems Expertise: PLCs, motion, HMIs, vision systems...
center, and Indy parenteral manufacturing to define the manufacturing process and validation strategy. Support the definition...
, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation... in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO...
and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations... metrics for trends at the CM Support Qualifications/ Validation document creation and reviews Provide and coordinate...
, identifying relevant tasks and data sources. Model Validation in MTL: Establish rigorous validation and evaluation frameworks...
Foundry are compliant with current computer systems validation expectations. This will include coordinating with the Foundry... of computer systems validation support, including System Development Lifecycle knowledge, problem solving, project management...
or qualified state. Understand, justify and document the state of validation with data that evaluate the capability of the...
organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in clinical trials... and biomarker assay development and validation and managing external vendors is a plus. Experience as bioanalytical/immunogenicity...
Control activities Experience on equipment qualification, system validation and process validation. Thorough technical...
following tasks related to the automated device assembly equipment design, delivery, and qualification/validation...
impurities). Demonstrated registration stability, process validation, or post-approval process development leadership. Track...
, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports... and mentoring. Previous equipment qualification and process validation experience. Previous experience with deviation and change...
and writing Computer System Validation documents. Up to 15% domestic and international travel required. #LI-DNI JOB LOCATION...
, development and validation history Translating process requirement and education to the Joint Process team members Documenting..., and sterility and Bioburden control (for parenteral product) strategies and validation process (PV/PPQ) and oversight...
, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs... business needs. Previous equipment qualification and process validation experience. Previous experience with deviation...
with drafting protocols for non-routine testing or validation with appropriate guidance. Assist in developing equipment...
and control of the manufacturing environment. Plant hygiene. Process validation. Training. The approval and monitoring...
system validation. In addition to creation, execution, and coordination of validation activities in unison with contract...
methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery Gather and influence...
with regulatory expectations. Provide technical oversight of third-party organizations throughout the transfer, validation... development and validation and managing external vendors is highly desired. Scientific knowledge of preclinical immunogenicity...