Engineer at NEPHRON SC, LLC

West Columbia, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Dec, 25

Salary

0.0

Posted On

17 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, cGMP Compliance, Project Management, Equipment Design, Technical Support, Collaboration, Six Sigma, Mechanical Design, Troubleshooting, Regulatory Knowledge, Quality Control, Documentation, Process Improvement, Audit Compliance, Microsoft Office, Engineering Principles

Industry

Pharmaceutical Manufacturing

Description

Description Job Purpose: 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. __________________________________________________________________________________________ Essential Duties and Responsibilities: Ø 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. Ø 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. Ø Responsible for implementation of new processes while maintaining cGMP compliance. Ø Team member and subject matter expert for the generation of User Requirement Specification documents for new equipment. Ø Manages capital projects from a small to medium scope requiring moderate coordination. Ability to manage several assignments (project & process duties) simultaneously is required. Ø Ensure all equipment is in compliance with established safety standards. Ø Responsible for acquiring and reviewing equipment/materials quotations. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment. Ø All other duties as assigned or apparent. Ø Ability to interact with all levels of management. Ø Ability to work in collaboration with machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required. Ø As required within the scope of the project, responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc. Ø Leads process improvement activities. Must have ability to design and implement machine modifications. Supplemental Functions: Ø Performs other similar duties as required. __________________________________________________________________________________________ Knowledge & Skills: Ø Work with Engineering Manager to design, evaluate, and optimize pharmaceutical manufacturing processes to increase efficiency, reduce waste, and improve quality while adhering to regulatory requirements. Ø Work with Engineering Manager to develop process development studies. Ø Work with Engineering Manager to generate protocols and summary analysis of results for process changes or new products. Ø Work with Engineering Manager to ensure manufacturing operations adhere to all industry regulations, including GMP, FDA, and internal quality standards. Perform routine audits and inspections to ensure compliance. Ø Work with Engineering Manager to support engineering projects, including the design and implementation of new processes or systems. Develop project plans, timelines, and budgets to ensure successful completion. Ø Identify and resolve issues with manufacturing equipment, processes, or systems. Provide technical support for production-related challenges. Ø Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects. Ø Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team Ø The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals Ø Willingness to participate in training and gain other certifications as needed. Ø Six Sigma certification (greenbelt or blackbelt) preferred. Ø Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred. Ø Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting. Ø Familiarity with the following processes: liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling Ø Proficient in Microsoft Office Suite with a strong knowledge in Word, Excel. Ø Highly organized with the ability to manage multiple projects and changing priorities Ø Assists with additional work duties or responsibilities as evident or required. Ø MUST have a valid driver’s license or government issued ID. Ø MUST pass a drug test. Ø Salary range: Based on experience Education / Experience: · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related field. · 1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP. · Familiarity with the implementation of process automation and control systems is preferred. · Knowledge of validation processes in pharmaceutical manufacturing is preferred. · Familiarity with FDA regulations, GMP, and other regulatory requirements governing pharmaceutical manufacturing is preferred. · cGMP Pharmaceutical/Biotech experience is preferred. __________________________________________________________________________________________ Working Conditions / Physical Requirements: · Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking. __________________________________________________________________________________________

Responsibilities

The Engineer will ensure the efficient design, optimization, and maintenance of manufacturing systems and processes. This role involves driving continuous improvement in production operations and collaborating with cross-functional teams.