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9 phones found area 269, 202, 970, 513, 360, 407, and 843
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Daniel Kaczka is listed as Associate Director, MODA Implementation (Validation) at Lonza Biosciences, based in Wayne, Pennsylvania, United States. AeroLeads shows a work email signal at att.net, phone signal with area code 269, 202, 970, 513, 360, 407, 843, and a matched LinkedIn profile for Daniel Kaczka.
Daniel Kaczka previously worked as Validation Manager (Sr Validation and Documentation Specialist) at Lonza Bioscience Informatics and Validation Section Manager: APCS at Icumedical. Daniel Kaczka holds Bs, Electronics Management from Southern Illinois University, Carbondale.
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25+ years of pharmaceutical process, quality and validation experience in a wide range of processes. Including; process validation, sterilization process validation, cleaning validation, equipment qualification, facilities/utilities qualification, automation/computerized systems validation, enterprise IT systems validation, and data integrity. Strong experience with quality systems including change management, training, maintenance management, and deviations/CAPAs. Thorough working knowledge of FDA, EMA, ICH and other international regulations. Experienced with presenting during regulatory audits (FDA, EMEA, PDMA, etc...), preparing FDA filings, and preparing responses.
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Manage the overall validation strategy for Lonza Informatics global products. Collaborate with Quality Assurance to design and implement the validation strategy to support commercial software releases.Provide technical leadership and accountability for Lonza Informatics validations. Implemented global instance of Kneat for paperless validation.
Manage the overall validation strategy for Lonza Informatics products. Collaborate with Quality Assurance to create and execute validation documentation.Provide technical leadership and accountability for Lonza Informatics validations.Develop validation strategies for Lonza Informatics validations, ensuring compliance to required regulatory.
Manage the automated process control and computer system validation group.
Fort Collins, CO, US
Completed successful PAI for new sterile injectable filling area, including lyophilization. Responsibility for process validation, cleaning validation, facilities/utilities qualification, equipment qualification aseptic filling and non-sterile fill/packaging, and computer validation.
Fort Collins, CO, US
Managed the site validation efforts, including Validation Engineers/Technicians, and various contractors based on site prioritization of projects to maintain compliance and support site priority projects. Validation oversight for process qualification program (CIP, COP, SIP, Media Challenges, and Product Validation). Delivered two new aseptic processing.
Cambridge, Cambridgeshire, GB
Change in site ownership. Manage site validation department including 7 engineers and 6 technicians. Oversight for process validation activities for Bulk Sterile Manufacturing, Sterile Powder Filling, Inspection, and Packaging. Direct validation support for QC Chemistry/Microbiology laboratory systems (including Empower) and temperature mapping of various.
Lawrence Township, NJ, US
Same Facility - Manage validation support for QC Chemistry/Microbiology laboratory systems (including Empower) and temperature mapping of various controlled temperature storage areas utilizing Kaye Validator/Valprobe, and Ellab systems. Manage validation support for maintenance management system (MAXIMO) and environmental monitoring systems (MODA). Managed.
Lawrence Township, NJ, US
New company, same facility. Manage validation support for QC Chemistry/Microbiology laboratory systems (including Empower) and temperature mapping of various controlled temperature storage areas utilizing Kaye Validator/Valprobe, and Ellab systems. Manage validation support for maintenance management system (MAXIMO) and environmental monitoring systems.
San Diego, CA, US
Manage validation support for QC Chemistry/Microbiology laboratory systems (including Empower) and temperature mapping of various controlled temperature storage areas utilizing Kaye and E-lab systems. Manage validation support for maintenance management system (MAXIMO) and environmental monitoring systems (MODA). Managed activities for cleaning.
New York, New York, US
Supported numerous validation projects throughout the facility. Specialized in automation and computer system projects including control system replacements (PLCs and Batch Management Systems) and automation changes for systems that supported sterile filling operations, freeze drying, fluid and ointment production, clean utilities, and environmental.
Indianapolis, IN, US
Led project teams responsible for validation of sterile filling line equipment and freeze drying equipment. Created system specifications, validation plans, protocols and final reports. Performed protocol execution. Managed validation activities and project change control. Served as companies IT manager. Managed servers, purchasing, managed email services.
Washington, DC, US
Naval Nuclear Power Program. Qualified as Engineering Watch Supervisor, Engineering Duty Petty Officer, and Reactor Operator. Experience at all levels of Reactor Controls division on Ohio Class SSBN. Instructor at Nuclear Field 'A" school. Certified as a Master Training Specialist. Performed classroom instruction on analog and digital electronics. Led.
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Daniel Kaczka works for Lonza Biosciences.
Daniel Kaczka is listed as Associate Director, MODA Implementation (Validation) at Lonza Biosciences.
AeroLeads has found 1 work email signal at @att.net for Daniel Kaczka at Lonza Biosciences.
AeroLeads has found 9 phone signal(s) with area code 269, 202, 970, 513, 360, 407, 843 for Daniel Kaczka at Lonza Biosciences.
Daniel Kaczka is based in Wayne, Pennsylvania, United States while working with Lonza Biosciences.
Daniel Kaczka has worked for Lonza Biosciences, Lonza Bioscience Informatics, Icumedical, Tolmar Inc., and Astrazeneca.
You can use AeroLeads to view verified contact signals for Daniel Kaczka at Lonza Biosciences, including work email, phone, and LinkedIn data when available.
Daniel Kaczka holds Bs, Electronics Management from Southern Illinois University, Carbondale.
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