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The automation engineer must have a background in PLCs, Emerson DeltaV DCS and some other computer system validation experience will suffice with the proper amount of programming, coding or batching.
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The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
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We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases.
$126,500 - $160,100 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Self-reliant definition of Validation Strategy in accordance with regulatory and customer requirements following risk-based approach (documentation in VMP and CRS/PRS) Self-reliant surveillance of validation activities in accordance with validation master plan, Product Specifications (e.g. CRS) and qualification / validation plans.
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The Process Controls and Validation Engineer provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
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Preferred certifications: Certified Quality Engineer and/or Certified Reliability Engineer, Lean Six Sigma Green Belt or Black Belt. Knowledge of terminal sterilization of medical devices (EO/Gamma/I-Beam), including validation processes, preferred.
$100,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.- Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity.
$52 - $57 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Test engineering, Validation, Test Case Development, manual testing, Test automation, API Testing, REST API, Swagger, Postman, Curl, Selenium, Azure, NoSQL, Azure DevOps, software verification, software validation, MySQL, PostgreSQL, MariaDB, SQLite, Microsoft SQL Server.
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Responsible for regulatory internal reporting, internal auditing and validation of compliance activities and reporting all relevant accidents and dangerous occurrences to the EHS Manager.
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Etc), hazard communication, control of change, hazardous waste management, reporting site key performance factors, Green House Gas data, chemical management systems and programs, personal protective equipment, dangerous goods – hazardous materials management, emergency preparedness, regulatory reporting and data collection.
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance.
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Responsible for all aspects of product design including - systems architecture, electrical engineering design, component selection, embedded systems / microprocessor based design and programing, requirements documentation, design verification, design validation, regulatory compliance, test plan creation, test tools and test scripts development, DFM/DFT, design reviews, and DFMEA. Lead projects ranging from short-term technology investigations to full-scale product development.
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This Process Engineer will ideally work out of one of our following locations: Hackettstown, NJ | Warwick, NY | Holyoke, MA | West Haven, CT. This engineer will be expected to travel 50% of the time to our locations in NY, NJ, MA, MD, CT, PA. Responsibilities Conduct extraction process development work from bench top pilot projects through production scale batches, via experimental design and process validation.
$80,000 - $100,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Sr. Validation Engineer to support our Cell Therapy Manufacturing facility located in Memphis, TN. The Sr. Engineer will have the experience to be functional lead responsible for Validation (CQV) deliverables for the facility, utilities, systems and equipment (FUSE.
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May perform hazardous waste regulatory audits followed by issuing corrective action and even escalation for issues of non-compliance with governmental regulations and Jabil policy when non-compliance is not addressed timely or for repeat offenses.
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