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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.
