Engineer at Nephron Pharmaceuticals – West Columbia, South Carolina

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:

· 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.

· 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.

· Responsible for implementation of new processes while maintaining cGMP compliance.

· Team member and subject matter expert for the generation of User Requirement Specification documents for new equipment.

· Manages capital projects from a small to medium scope requiring moderate coordination. Ability to manage several assignments (project & process duties) simultaneously is required.

· Ensure all equipment is in compliance with established safety standards.

· Responsible for acquiring and reviewing equipment/materials quotations. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment.

· All other duties as assigned or apparent.

· Ability to interact with all levels of management.

· Ability to work in collaboration with machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required.

· As required within the scope of the project, responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.

· Leads process improvement activities. Must have ability to design and implement machine modifications.

Supplemental Functions:

· Performs other similar duties as required.

Knowledge & Skills:

· Must have bachelor's degree in engineering. Mechanical, Electrical, Biomedical, or Chemical Engineering preferred.

· 1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP.

· Exceptional technical writing and documentation skills.

· 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.

· Advanced proficiency in Microsoft Word for authoring, formatting, and maintaining GMP-compliant technical documents (protocols, reports, SOPs, specifications).

· Attention to detail and commitment to data integrity

· Working knowledge of Microsoft Excel for data analysis, trending, calculations, tables, and graphical presentation of engineering and development data.

· Highly organized with the ability to manage multiple projects and changing priorities while under pressure

· Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects.

· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team

· Effective verbal and written communication

· Ability to work independently while collaborating across teams

· Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting.

· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.

· Knowledge of PLC, Vision Systems, and equipment troubleshooting preferred.

· Experience in manufacturing environment. Pharmaceutical or Medical Device experience highly preferred.

· Six Sigma certification (greenbelt or blackbelt) preferred.

Familiarity with the following processes: liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling.

· Highly organized with the ability to manage multiple projects and changing priorities while under pressure.

· Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team

· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.

· MUST have a valid driver’s license or government issued ID.

· MUST pass a drug test.

Working Conditions / Physical Requirements:

· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.