5796 Validation Engineer I
Responsibilities:Support the development, execution, and management of the timelines for the execution of CD/PQ/CV/PV/RV activities.With the support of the validation manager, learn to prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities.Track and trend activities and report out on issues such as impact to predetermined […]
5509 Validation Engineer II
Description:This position provides support for analytical instrument qualification and validation for research and early phase drug development.Position maintains lifecycle of GMP systems for testing of early clinical stage compounds from initial qualification to retirement, including data archival, in addition to numerous R&D systems.We are seeking a candidate experienced in equipment […]
4630 Process Validation Associate
SummaryResponsible for supporting process validation (PV) activities.Deliverables include management of PV document schedule, facilitating document reviews, assisting with PV sampling activities (lab).Will also assist with large and small-scale PV and tech transfer studies, as needed. Job ResponsibilitiesEssential:Assist with PV document reviews for Process Engineering:Manage document review workflows; ensure correct content […]
4135 Cleaning Validation and Qualification Support
Description:Relative Cleanability Studies.Support lab coupon studies to determine the cleanability new tech transfer products are compared to current products.Experience with lab scale studies and data analysis.Support pilot plant cleanability studies. Equipment QualificationSupport equipment qualification due to equipment modifications for tech transfers. Tech transfer activitiesWriting Cleaning Confirmation or Validation Protocols and […]
4064 Cell Culture Associate
Position and Candidate Description:The contractor will support the tech transfer and commercial production of monoclonal antibody processes. Tech transfer activities will support the execution of engineering runs and process performance qualification runs at the facility. Commercial production activities will support process monitoring to ensure the commercial process remains in a […]
3600 Validation Engineer I
Description:Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the Company corporate principles, quality policies, standards, and core values.You will work closely with instrument vendors, facilities, IT and lab personnel to coordinate the acquisition, installation, […]
4102 Validation Engineer II
DUTIES:This position will support completion of process validation projects related to the implementation of new manufacturing processes and changes to existing processes for drug substance manufacturing processes, drug product filling, process simulations (media fills), filtration, mixing, sterilization, lyophilization, vial & syringe filling, API chemical synthesis, blending, tableting, powder filling, and […]
3098 Validation Specialist III
Duties:Site/Commercial Quality Control is seeking an associate to plan, coordinate, execute and document qualification of QC equipment and associated software.The person is also responsible for equipment maintenance and management of equipment qualification and maintenance records.The successful candidate who has demonstrated outstanding performance will have priority to be considered for regular […]
3129 Verification and Validation Engineer
Duties:The Device Development group is searching for an experienced Engineer to provide development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.The candidate should have expertise in (verification) testing, systems and methods qualification & validation, maintenances of Laboratory Equipment, and support other engineering and […]
5285 Validation Engineer
Duties:The Validation Engineer IV position is responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Vacaville Commercial Manufacturing Facility.Performance of such validation activities include Equipment/Utility/Facility Qualification, Cleaning Validation, Steaming/Sanitization/Sterility Validation and Automation System Qualification across the […]