Engineer

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    "html_title": "Nephron Pharmaceuticals - Engineer",
    "description_html": "<p>This position will be responsible for ensuring the efficient design, optimization, and maintenance of manufacturing systems and processes to meet quality, safety, and regulatory standards. This role plays a key part in driving continuous improvement in production operations, working closely with cross-functional teams to enhance production efficiency, reduce costs, and maintain product quality.&nbsp;</p><p>&nbsp;&nbsp;</p><p><strong>Essential Duties and Responsibilities:</strong></p><p>· Team member and subject matter expert on cross functional team to develop Process Development Studies. Responsible for protocol generation and summary analysis of results for process changes or new products.</p><p>· Team member and subject matter expert for the design and implementation of new equipment and equipment modifications to help improve safety, Quality, reliability, and throughput.</p><p>· Responsible for implementation of new processes while maintaining cGMP compliance.</p><p>· Team member and subject matter expert for the generation of User Requirement Specification documents for new equipment.</p><p>· Manages capital projects from a small to medium scope requiring moderate coordination. Ability to manage several assignments (project &amp; process duties) simultaneously is required.</p><p>· Ensure all equipment is in compliance with established safety standards.</p><p>· Responsible for acquiring and reviewing equipment/materials quotations. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment.</p><p>· All other duties as assigned or apparent.</p><p>· Ability to interact with all levels of management.</p><p>· Ability to work in collaboration with machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required.</p><p>· As required within the scope of the project, responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.</p><p>· Leads process improvement activities. Must have ability to design and implement machine modifications.</p><p>&nbsp;&nbsp;</p><p><strong>Supplemental Functions:&nbsp;</strong></p><p>· Performs other similar duties as required.</p>",
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      "description": "<p>Description</p><p>This position will be responsible for ensuring the efficient design, optimization, and maintenance of manufacturing systems and processes to meet quality, safety, and regulatory standards. This role plays a key part in driving continuous improvement in production operations, working closely with cross-functional teams to enhance production efficiency, reduce costs, and maintain product quality. </p><p>  </p><p><strong>Essential Duties and Responsibilities:</strong></p><p>· Team member and subject matter expert on cross functional team to develop Process Development Studies. Responsible for protocol generation and summary analysis of results for process changes or new products.</p><p>· Team member and subject matter expert for the design and implementation of new equipment and equipment modifications to help improve safety, Quality, reliability, and throughput.</p><p>· Responsible for implementation of new processes while maintaining cGMP compliance.</p><p>· Team member and subject matter expert for the generation of User Requirement Specification documents for new equipment.</p><p>· Manages capital projects from a small to medium scope requiring moderate coordination. Ability to manage several assignments (project & process duties) simultaneously is required.</p><p>· Ensure all equipment is in compliance with established safety standards.</p><p>· Responsible for acquiring and reviewing equipment/materials quotations. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment.</p><p>· All other duties as assigned or apparent.</p><p>· Ability to interact with all levels of management.</p><p>· Ability to work in collaboration with machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required.</p><p>· As required within the scope of the project, responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.</p><p>· Leads process improvement activities. Must have ability to design and implement machine modifications.</p><p>  </p><p><strong>Supplemental Functions: </strong></p><p>· Performs other similar duties as required.</p><p>Requirements</p><p>  </p><p><strong>Knowledge & Skills: </strong></p><p>· Must have bachelor's degree in engineering. Mechanical, Electrical, Biomedical, or Chemical Engineering preferred.</p><p>· 1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP.</p><p>· Exceptional technical writing and documentation skills.</p><p>· Knowledge of validation processes in pharmaceutical manufacturing is preferred.</p><p>· Familiarity with FDA regulations, GMP, and other regulatory requirements governing pharmaceutical manufacturing is preferred.</p><p>· cGMP Pharmaceutical/Biotech experience is preferred.</p><p>· Advanced proficiency in Microsoft Word for authoring, formatting, and maintaining GMP-compliant technical documents (protocols, reports, SOPs, specifications).</p><p>· Attention to detail and commitment to data integrity</p><p>· Working knowledge of Microsoft Excel for data analysis, trending, calculations, tables, and graphical presentation of engineering and development data.</p><p>· Highly organized with the ability to manage multiple projects and changing priorities while under pressure </p><p>· Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects.</p><p>· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team</p><p>· Effective verbal and written communication</p><p>· Ability to work independently while collaborating across teams </p><p>· Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting.</p><p>· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.</p><p>· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.</p><p>· Experience in manufacturing environment. Pharmaceutical or Medical Device experience highly preferred.</p><p>· Six Sigma certification (greenbelt or blackbelt) preferred.</p><p>Familiarity with the following processes:  liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling. </p><p>· Highly organized with the ability to manage multiple projects and changing priorities while under pressure. </p><p>· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team</p><p>· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.</p><p>· MUST have a valid driver’s license or government issued ID.</p><p>· MUST pass a drug test.</p><p>  </p><p><strong>Working Conditions / Physical Requirements:</strong></p><p>· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.</p>",
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          "addressRegion": "SC",
          "streetAddress": "4500 12th Street Extension",
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    "requirements_html": "<p>&nbsp;&nbsp;</p><p><strong>Knowledge &amp; Skills:&nbsp;</strong></p><p>· Must have bachelor's degree in engineering. Mechanical, Electrical, Biomedical, or Chemical Engineering preferred.</p><p>· 1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP.</p><p>· Exceptional technical writing and documentation skills.</p><p>· Knowledge of validation processes in pharmaceutical manufacturing is preferred.</p><p>· Familiarity with FDA regulations, GMP, and other regulatory requirements governing pharmaceutical manufacturing is preferred.</p><p>· cGMP Pharmaceutical/Biotech experience is preferred.</p><p>· Advanced proficiency in Microsoft Word for authoring, formatting, and maintaining GMP-compliant technical documents (protocols, reports, SOPs, specifications).</p><p>· Attention to detail and commitment to data integrity</p><p>· Working knowledge of Microsoft Excel for data analysis, trending, calculations, tables, and graphical presentation of engineering and development data.</p><p>· Highly organized with the ability to manage multiple projects and changing priorities while under pressure&nbsp;</p><p>· Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects.</p><p>· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team</p><p>· Effective verbal and written communication</p><p>· Ability to work independently while collaborating across teams&nbsp;</p><p>· Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting.</p><p>· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.</p><p>· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.</p><p>· Experience in manufacturing environment. Pharmaceutical or Medical Device experience highly preferred.</p><p>· Six Sigma certification (greenbelt or blackbelt) preferred.</p><p>Familiarity with the following processes: &nbsp;liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling.&nbsp;</p><p>· Highly organized with the ability to manage multiple projects and changing priorities while under pressure.&nbsp;</p><p>· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team</p><p>· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.</p><p>· MUST have a valid driver’s license or government issued ID.</p><p>· MUST pass a drug test.</p><p>&nbsp;&nbsp;</p><p><strong>Working Conditions / Physical Requirements:</strong></p><p>· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.</p>",
    "requirements_text": "Knowledge & Skills:\n · Must have bachelor's degree in engineering. Mechanical, Electrical, Biomedical, or Chemical Engineering preferred.\n · 1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP.\n · Exceptional technical writing and documentation skills.\n · Knowledge of validation processes in pharmaceutical manufacturing is preferred.\n · Familiarity with FDA regulations, GMP, and other regulatory requirements governing pharmaceutical manufacturing is preferred.\n · cGMP Pharmaceutical/Biotech experience is preferred.\n · Advanced proficiency in Microsoft Word for authoring, formatting, and maintaining GMP-compliant technical documents (protocols, reports, SOPs, specifications).\n · Attention to detail and commitment to data integrity\n · Working knowledge of Microsoft Excel for data analysis, trending, calculations, tables, and graphical presentation of engineering and development data.\n · Highly organized with the ability to manage multiple projects and changing priorities while under pressure\n · Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects.\n · Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team\n · Effective verbal and written communication\n · Ability to work independently while collaborating across teams\n · Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting.\n · Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.\n · Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.\n · Experience in manufacturing environment. Pharmaceutical or Medical Device experience highly preferred.\n · Six Sigma certification (greenbelt or blackbelt) preferred.\n Familiarity with the following processes: liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling.\n · Highly organized with the ability to manage multiple projects and changing priorities while under pressure.\n · Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team\n · Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.\n · MUST have a valid driver’s license or government issued ID.\n · MUST pass a drug test.\n Working Conditions / Physical Requirements:\n · Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking."
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      "Address": "4500 12th Street Extension",
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