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Support line validation / qualification activities for including IQ, OQ, MSA and PQ. Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.
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8-10 years of experience with ontology evaluation, validation, and quality assurance processes. Conduct ontology quality assurance activities including consistency checks, logical reasoning, and validation against odmain data.
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The TS Engineer I provides direct validation support to pharmaceutical development and manufacturing operations. Exposure to Technical Service /Product Development, Formulation, Process Validation and/or Cleaning Validation through pharmaceutical or biotechnology industry experience.
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Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry. Maintains Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental roll-outs.
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Piper Companies is currently seeking a Pharmaceutical Equipment Commissioning & Qualification Engineer for an opportunity in Titusville, New Jersey (NJ) , to join a global pharmaceutical company.
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LHH Recruitment Solutions has a fully on-site 5 days a week PCB Design/Embedded Engineer (ELECTRONICS - MCU) for our client in the Dayton, NJ area. This hands on, on-site role delves into product validation, hardware development, pre-certification testing, and firmware development.
$90,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Responsible for the entire life cycle of equipment Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment and System Design Specifications (SDS.
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Support the computer system validation (CSV) activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines. Understanding of cGMP, cGDP, and computer system Validation (CSV.
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Startup support including process validation, cGMP implementation, tuning of control strategy, process safety assurance, etc. Process development including pilot plant design, operation, data interpretation, and design for robustness.
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Validation Engineer Internship. Join us for an electrifying summer as a Validation Engineering Intern! Work alongside our Validation Engineers to work on and validate our cutting-edge machinery and instruments, from bioreactors to refrigerators to spectrophotometers.
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The CSV Engineer collaborates with QA, IT, and business users to define user requirements and understand system functionality for computerized systems and data integrity. Prepares and reviews validation documentation such as Validation Plans, User Requirements, Protocols (IQ/OQ/PQ), Gap Analyses, Trace Matrix, and Validation Summary Reports.
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And minimum 1 year experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry. and minimum 2 years experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry.
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The Qualification Engineer supports and assists the Facilities & Engineering department with writing and execution of various qualification protocols for production and critical utilities equipment to meet production requirements including deadlines and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements.
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Validation Engineer Parenteral/ Aseptic Processing CQV. Candidates need to have experience in the qualification of Commercial Filling Line Equipment and Isolators (SKAN, Bausch+Strobel, GEA, VarioSys.
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Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)Spray coverage testing, cleaning verification swabbing, and sample submission practicesProvide process engineering support for clean water systems, CIP, SIP validation risk assessments, and pharmaceutical process equipment.
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validation engineer jobs in Princeton, NJ
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