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 […]
0830 Cleaning Validation and Qualification Support
Duties: 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.Support equipment qualification due to equipment modifications for tech transfers.Tech transfer activities – Writing Cleaning Confirmation or Validation Protocols and […]
8705 Validation Engineer I
Duties:Execute equipment qualification testing (IQ, OQ, and PQ) and generate related documentation (e.g. protocols, reports). Work with supervisor/ manager and system owners to maintain schedule and resolve issues. Ability to lead teams composed of validation professionals and, to perform analysis of current business processes to translate development documents into user […]
3342 QC Associate II
Duties: Installation and operational qualification (IQ and OQ) of five Milli-Q point of use water treatment units. This includes creation and execution of IQ/OQ protocols. All protocols must be pre-approved prior to execution and post approved following execution by the Company.Decommissioning of one TOC 900 instrument and IQ, OQ, and […]
Validation Specialist I
Duties:The candidate will be responsible for supporting validation activities.This includes supporting Periodic Reviews of validated equipment, which entails review of lifecycle documents.These reviews will be compiled in a Periodic Review summary report.The contractor will support revalidation execution on equipment to ensure the equipment has been operating in a validated state, […]