Engineer

Description

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.

Requirements

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.