Engineer

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.

__________________________________________________________________________________________