Engineer

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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.