- Beckman Coulter Diagnostics (Miami, FL)
- …experience, OR Doctoral degree in fieldExperience in software, test method, equipment , process , and/or design testing methodologies.Knowledge of FDA regulations, ... ISO standards, and GxP guidelines.Experience with Computer System Validation (CSV) and process validationIt would be a plus if you also possess previous… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …that safeguard and improve human health.This position is part of the Operations Process Engineering Department located in Coralville, Iowa and will be on-site. At ... to populate the VAVE funnel with vetted and appropriately valued opportunitiesDevelop validation plans and assist with VAVE projects to realize efficiencies on… more
- Cytiva (Miami, FL)
- …manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis and CAPA initiatives, ensuring ... nonconformances to maintain product quality and customer satisfaction; overseeing manufacturing validation (IQ, OQ, PQ) and design assurance activities to support… more
- Raytheon (Los Angeles, CA)
- …principles, test methodologies, and the ability to work with advanced test equipment and cutting edge technology. You will collaborate closely with design engineers, ... for RF systems and components.Perform RF testing using advanced test equipment such as spectrum analyzers, network analyzers, and signal generators.Troubleshoot and… more
- Raytheon (Tucson, AZ)
- …Immigration Status Requirements: Security Clearance: DoD Clearance: Secret The Test Equipment Engineering (TEE) organization within RTX drives business success by ... Travel up to 20% to support development and/or delivery of our test environment equipment . What You Will Learn: System level test setup and operation across the… more
- Cytiva (Miami, FL)
- …and maintain process documentation, including standard operating procedures (SOPs), process flows, and validation reports.Design, test, and implement new ... processes, managing projects, and ensuring the efficient production of high-quality medical devices and products in a regulated environment. The ideal candidate… more
- Actalent (St. Louis, MO)
- …Provide guidance and training to laboratory staff on validation procedures and equipment use. Skills Equipment validation , Validation protocols ... or a related scientific discipline. * Experience: Previous experience in equipment validation , particularly IQ/OQ/PQ processes, within a regulated environment… more
- United Therapeutics (Silver Spring, MD)
- …Validation Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment , process and/or computer-related ... Equipment , you'll be a subject matter expert in equipment validation , playing a key role in...enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Process Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... Pharma Solutions in Harmans, MD is hiring a Senior Process Validation Engineer who is responsible for...who is responsible for the qualification of cGMP manufacturing equipment cleaning processes and/or manufacturing processes. It is critical… more
- Danaher Corporation (Fargo, ND)
- …development and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department ... discoveries worldwide. You will be a part of the Process Validation team and report to the...will have the opportunity to: + Develop and review validation documents for facilities, equipment , and processes.… more
- Curia (Rensselaer, NY)
- … process and cleaning validation protocols and master plans, supervises validation activities such process / equipment / cleaning/ computer system ... in one or more core validation areas ( Equipment qualification, packaging, cleaning, utilities, process or...Familiar with FDA and EU regulations for pharmaceuticals and medical devices + Strong technical writing skills are required… more
- Abeona (Cleveland, OH)
- …etc.) + 8+ years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company + Must be ... is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation … more
- Astellas Pharma (Westborough, MA)
- …capital projects. + Provide guidance for commissioning and qualification of facilities/utilities, equipment , automated systems, and process validation . + ... Author, execute, review, and approve validation documentation for facilities/utilities, equipment , automated systems, and process validation and assist… more
- Catalent Pharma Solutions (Harmans, MD)
- …electronic data integrity. + Review and approve Protocols and Summary Reports for Process Validation such as PPQ's, Engineering studies, Cleaning Validation , ... **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking...product. This position will provide continuous improvement support to process , equipment , utilities and computer systems and… more
- BeOne Medicines (San Mateo, CA)
- …operations. + Lead the design, implementation, maintenance, and continuous improvement of validation and manufacturing process elements in the QMS. + Define ... or medical devices). + Proven experience with QMS implementation and process ownership. + Deep expertise with Valiation ( equipment , process ,… more
- PCI Pharma Services (Philadelphia, PA)
- …responsibilities include generating and executing validation protocols for packaging and assembly equipment , as well as process validation . The role also ... Specialist plays a key role in the qualification and validation of medical device assembly equipment...a GMP-regulated environment. Experience with development and execution of validation protocols for process , equipment ,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …in comprehension/application of USDA and FDA/EU regulatory requirements for validation /qualification of equipment / process /cleaning of regulated biological ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues...and is responsible for assuring compliance of validated systems, process , equipment to current cGMP, FDA, EU,… more
- Novo Nordisk (Durham, NC)
- …production sites + Perform & review system, equipment , utility, & process revalidation per corporate science & risk-based validation principles + ... experience required + Minimum of five (5) years of validation related discipline experience in pharmaceutical or medical...documents required + Experience in one or more core validation areas ( equipment , cleaning, process ,… more
- Charles River Laboratories (Memphis, TN)
- …reports. * Execution of qualification/ validation protocols for cell processing equipment , lab instruments, cleaning, process , shipping, test method and other ... Manager Validation , the Validation Engineer II supports the qualification/ validation programs for equipment , instruments, and facility used in cellular… more
- Kedrion Biopharma (Melville, NY)
- …and perform Qualification and Validation activities related to process , cleaning, and equipment . Partners with Engineering, Maintenance, Manufacturing, ... of Fractionation intermediates and final sterile drug product. + Support execution of process validation activities. + Performs generation of summary reports for… more
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