Manufacturing Engineer III
2 weeks ago
Responsibilities: ssist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective. Process engineering and project management to support remediation projects. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly. Complete projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting. Must be able to perform/deliver specific project tasks as necessary Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO). Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings. Support projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes. Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. s required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support). Participate and collaborate in technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities. Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc. Provide technical input for analysis of process and equipment changes. pply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing. Evaluate and upgrade process equipment as required. Execute other work as assigned by management Requirements: Bachelor's degree in engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering). 3+ years of experience in manufacturing engineering within the medical device industry. Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required. Experience with Statistical Process Control tools required (SPC, Minitab, other software). General chemistry, processing, and material expertise. Considerable knowledge of the principles and practices of engineering as applied to various types of projects. bility to prepare complex technical reports, project summaries, and correspondence. Exceptional practical problem-solving skills, excellent organizational and communication skills.
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Downstream Manufacturing Scientist
3 weeks ago
Cranbury, United States Medix™ Full timePosition SummaryThe Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in...
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Downstream Manufacturing Scientist
3 weeks ago
Cranbury, United States Medix™ Full timePosition SummaryThe Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in...
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Civil Project Engineer
2 weeks ago
Cranbury, United States Pharmaceutical Manufacturer Full timeJob DescriptionJob Description Our client is a growing pharmaceutical company. Because of this growth, they are looking for a civil engineer to guide them through construction projects for new facilities in the area as well as revamping current facilities. You will be working with contractors as well as manufacturing professionals and will have the following...
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IT Engineer
2 weeks ago
Cranbury, United States J-STAR Research Full timePorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering high-quality products and...
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Lead Electrical Engineer
4 weeks ago
Cranbury, United States EG&R Engineering PC Full timeJob DescriptionJob DescriptionEG&R Engineering PC is a fast-growing multi-disciplinary engineering firm located in Cranbury, NJ. EG&R provides electrical, mechanical, environmental and geotechnical engineering services for a variety of markets including government, utilities/power, waste to energy companies, transit agencies, manufacturing industries,...
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Engineering Manager
2 weeks ago
Cranbury, United States EG&R Engineering PC Full timeJob DescriptionJob DescriptionEG&R Engineering PC is a fast-growing multi-disciplinary engineering firm located in Cranbury, NJ. EG&R provides electrical, mechanical, environmental and geotechnical engineering services for a variety of markets including government, utilities/power, waste to energy companies, transit agencies, manufacturing industries,...
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Engineering Manager Substation Power
2 weeks ago
Cranbury, United States EG&R Engineering PC Full timeEG&R Engineering PC is a fast-growing multi-disciplinary engineering firm located in Cranbury, NJ. EG&R provides electrical, mechanical, environmental and geotechnical engineering services for a variety of markets including government, utilities/power, waste to energy companies, transit agencies, manufacturing industries, pharmaceuticals, A-E...
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Assistant Project Manager
4 weeks ago
Cranbury, United States EG&R Engineering PC Full timeJob DescriptionJob DescriptionEG&R Engineering PC is a fast-growing multi-disciplinary engineering firm located in Cranbury, NJ. EG&R provides electrical, mechanical, environmental and geotechnical engineering services for a variety of markets including government, utilities/power, waste to energy companies, transit agencies, manufacturing industries,...
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Senior Validation Specialist
2 weeks ago
Cranbury, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities. ...
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Quality Assurance Specialist
3 weeks ago
Cranbury, United States Porton Pharma Solutions Ltd. Full timeJob descriptionJob Description– Quality AssurancePorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are...
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Quality Assurance Specialist
2 weeks ago
Cranbury, United States Porton Pharma Solutions Ltd. Full timeJob descriptionJob Description– Quality AssurancePorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are...
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Quality Assurance Specialist
3 weeks ago
Cranbury, United States Porton Pharma Solutions Ltd. Full timeJob descriptionJob Description– Quality AssurancePorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are...
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Environmental, Health, and Safety Supervisor
3 weeks ago
Cranbury, United States ANI Pharmaceuticals, Inc. Full timeAbout Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the...