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Deactivation protocols for the two assembly machines, labeler, tray unloader, conveyor system, cartridge reclaim machine, cartridge cleaning machine, cartoner, case packer, tamper evident labeler, and palletizer.
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Validation and system experience in the following applicable areas: Sterilization and aseptic processing validation. Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
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Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.
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Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization. Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering.
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The Cleaning Validation Engineer will be directly responsible for writing and executi ng cleaning validation documents; preparation and execution Cleaning Development, Cleaning Validation, and method validation is a plus.
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Job Purpose: The Cleaning Validation Engineer will be directly responsible for writing and executing cleaning validation documents; preparation and execution Cleaning Development, Cleaning Validation, and method validation is a plus.
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Authors, reviews, and approves commissioning, qualification and validation deliverables (URS, FAT, SAT, TOP, DQ, IQ, OQ, PQ, PPQ, CSV and PV (cleaning, sterilization) for facilities, utilities, equipment, computerized systems, Laboratory Instruments and processes related to compounding of sterile and non-sterile injectables.
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Responsible for the design, authorship, and execution of commissioning, qualification and validation studies for the any or more of the following major disciplines: Facilities, Utilities, and Equipment (FUE) qualification, Units operations automation qualification with Honeywell, Delta V, and PCL-based systems, Computerized systems validation, Cleaning validation, Sterilization validation, Materials validation, and Process validation.
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Prepare data for model training, validation, and testing using data cleaning, transformation, augmentation, and visualization techniques to improve data quality and utility for AI and ML models.
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Cleaning validation of manufacturing equipment. Sterilization and aseptic processing validation. Calculation and interpretation of data for commissioning, qualification and validation studies.
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We are looking to staff a Validation Engineer for a 9+ month contract with our for our client in the Greater San Diego area. 5 -7 years of relevant validation engineer experience.
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Cleaning, ACF bonding, automated inspection, photo chemical etching/machining (coat, expose, develop, etch, clean) and/or measurement. Strong oral communication skill and demonstrated technical writing skills: able to write detailed reports, comprehensive manufacturing procedures and assist Quality Engineering with validation protocols.
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Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. Engineering services may include cell management, process development, project management, process validation, tool design, and trouble shooting.
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The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements.
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You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.
ExpandApply NowActive JobUpdated 11 days ago
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