Career Opportunities
 Laura Davis Human Resources Director resumes@coldstreamlabs.com |
Process Engineer Back to top
This position is responsible for proactively driving the successful development, tech transfer, and engineering support of sterile parenteral products and new technologies to ensure successful production and release of clinical and commercial materials. This individual will work with clinical and ANDA projects to ensure manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization. This individual defines processing or handling equipment requirements and specifications. They will also review processing techniques and methods applied in the manufacture, fabrication of equipment, and evaluation of products. They will develop, review and approve protocols, reports, batch records, procedures, Critical process parameter justifications, risk assessments, and project schedules to ensure successful project execution
This individual will provide risk and process flow assessments and the appropriate experimental designs during the planning stage for scale-up and technology transfer. They will be responsible for process risk assessment, design, scale-up, process improvement, and manufacturing readiness of formulation, filtering, filling, terminal sterilization, and lyophilization operations.
This individual will participate in project teams; interact with peers at CLI including R&D, Validation, Operations, QA, and project management, and clients to insure reliable clinical and commercial supply and advance projects in a timely and cost effective way while maintaining quality. Troubleshoots existing development products and supports new product transfers. Leads a proactive effort to identify, evaluate and implement new technologies that will improve the quality and cost efficiency of parenteral manufacturing operations and processes.
Requirements: 4 year degree in engineering, chemistry or closely related field with demonstrated proficiency with experimental design, project management, statistics, and validation. Minimum of 4 years extensive pharmaceutical process development experience or advanced scientific degree in chemistry plus 2 years of pharmaceutical process development experience.
Senior Process EngineerBack to top
This position is responsible for proactively driving the successful development, tech transfer, and engineering support of sterile parenteral products and new technologies to ensure successful production and release of clinical and commercial materials. This individual will work with clinical and ANDA projects to ensure manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization. This individual defines processing or handling equipment requirements and specifications. They will also review processing techniques and methods applied in the manufacture, fabrication of equipment, and evaluation of products. They will develop, review and approve protocols, reports, batch records, procedures, Critical process parameter justifications, risk assessments, and project schedules to ensure successful project execution
This individual will provide risk and process flow assessments and the appropriate experimental designs during the planning stage for scale-up and technology transfer. They will be responsible for process risk assessment, design, scale-up, process improvement, and manufacturing readiness of formulation, filtering, filling, terminal sterilization, and lyophilization operations.
Education and Experience: 4 year degree in engineering, chemistry or closely related field with demonstrated proficiency with experimental design, project management, statistics, and validation. Minimum of 10 years extensive pharmaceutical process development experience or advanced scientific degree in chemistry plus 6 years of pharmaceutical process development experience
Maintenance Mechanic Back to top
The candidate responsibilities include to operate production machinery, test and inspect equipment for defects and malfunctioning (misalignment, wear, failure, etc), and to make permanent or temporary repairs/adjustments as needed. Responsibilities also determining the best way of making repairs, replacements and installations to minimize interruption of production. The maintenance mechanic will set up and operate simple machine tools, install piping, fixtures, new equipment panel boards, etc.
Must follow all company safety policies and procedures and follow job specific work instructions which pertain to the job assignment. The maintenance mechanic will receive and interpret instructions, work orders, and blueprints covering the scheduled and emergency repair, installation and inspection work to be done.
Requirements:Minimum 5 years experience as an Equipment Maintenance Mechanic in an industrial environment; previous experience in a regulated environment is a plus. High School Diploma required; Technical School preferred