Engineer

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.