• Principal Process Controls…

    Regeneron Pharmaceuticals (East Greenbush, NY)
    …support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or ... product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or… more
    Regeneron Pharmaceuticals (07/29/25)
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  • Manager QA Validation (Fill Finish)

    Regeneron Pharmaceuticals (East Greenbush, NY)
    …equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and ... The QA Validation Fill Finish team is hiring a Manager!...gloves and the use of sanitizing agents during gowning process including IPA) + Ability to remove jewelry, make-up… more
    Regeneron Pharmaceuticals (07/23/25)
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  • Senior QA Validation Specialist - CSV…

    Curia (Rensselaer, NY)
    …documents to maintain the validated state of equipment and processes and the validation + Identify process improvements before equipment, systems or processes ... review of documents + Expert competence in one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer… more
    Curia (09/19/25)
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  • Software Validation Engineer

    Harmac Medical Products (Buffalo, NY)
    …provide support to all Harmac Medical Product Facilities in the Computerized System Validation Process . This is a full time, salaried (exempt) position. This ... Software Validation Engineer About the Organization Harmac Medical Products,...to evaluate computerized systems based on applicability, functionality, and process and product safety. They will support management and… more
    Harmac Medical Products (07/24/25)
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  • Computer Systems Validation Specialist

    Unither Pharmaceuticals (Rochester, NY)
    …are completed. Validation Protocols and Documentation (200%) Writes validation protocols ( process validations for, manufacturing and packaging processes. ... Computer Systems Validation Specialist Who we are? We are a...approved report(s) within the appropriate project folder throughout the process of validating a system. Develop a standard operating… more
    Unither Pharmaceuticals (08/27/25)
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  • Laboratory Application Scientist

    Unither Pharmaceuticals (Rochester, NY)
    …experience in the pharmaceutical industry in Product Development, Technical Services, or Process Validation . Master's degree in life science such as Biology, ... in the pharmaceutical industry in Product Development, Technical Services, or Process Validation . Software and instruments experience, especially HPLC, LCMS,… more
    Unither Pharmaceuticals (09/27/25)
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  • Associate Director, MSAT, Downstream Drug…

    Otsuka America Pharmaceutical Inc. (Albany, NY)
    …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Validation Engineer

    Kelly Services (Rochester, NY)
    … Validation Engineer will be an integral part of the development process engineering team supporting all lab verification/ validation needs. This position will ... needs + Provide support to Software Quality Assurance representatives during MES validation of change control process . + Participate with the engineering… more
    Kelly Services (09/30/25)
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  • Manager Internal Fill/Finish MFG

    Regeneron Pharmaceuticals (East Greenbush, NY)
    …subject matter expert is preferred. + Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred. ... / finish subject matter expert (SME), coordinating with Combination Products, Validation and Quality Assurance (tech transfer studies / tech transfer,… more
    Regeneron Pharmaceuticals (08/22/25)
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  • Principal Fill/Finish MFG Engineer

    Regeneron Pharmaceuticals (East Greenbush, NY)
    …a positive team environment + Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred. ... fill/finish manufacturing facility. + Interfaces with other departments such as Engineering, Validation , DP Process Development, Process Analytical Sciences,… more
    Regeneron Pharmaceuticals (07/24/25)
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