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| ONLY SUBMIT 1 APPLICATION TO OUR SITE IN TWELVE MONTHS, AND QUALIFIED CANDIDATES WILL BE CONSIDERED FOR ANY OF OUR CURRENT OPEN POSITIONS THAT ONE MAY FIT. MULTIPLES WILL BE DISCARDED AND QUALIFIED CANDIDATES WILL BE HEARING DIRECTLY FROM ONE OF OUR RECRUITERS SOON. THANK YOU! |
Job Order#:
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21918 |
Location:
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CO, MI, NJ, PA |
Job Title:
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API PROCESS DEVELOPMENT ENGINEER |
Industry:
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pharmaceuticals |
Salary:
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to $107K |
Education:
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Chemical Engineering |
Expertise:
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process chemistry, crystallization, synthesis |
Description:
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The Process Development Engineer at this facility will be responsible for a variety of projects and must be flexible with a desire to achieve. This position will spend a portion of their time on benchwork in the lab. This position is under general supervision performing the design and implementation of manufacturing processes, instrumentation, and equipment from the laboratory through pilot plant and manufacturing scale.
ESSENTIAL FUNCTIONS:
Acts as company expert/resource regarding pharmaceutical process engineering, including process design and process scale-up, to include active participation in equipment setup and process execution. Actively develops and recommends new process improvements and new technologies to achieve cost effectiveness and improve product quality. Establishes operating equipment specifications and recommends improvements to manufacturing techniques. Actively participates in new product scale-up, process development and optimization, technology transfer and process validation activities. Interfaces directly with manufacturing staff and quality staff in order to ensure that processes and designs are compatible for new product technology transfer and meet API requirements. Drafts SOPs to document new process procedures or writes revisions to recognize changes through optimization or technology change. Also prepares, revises, or approves complex engineering studies, cost estimates, technical evaluations, protocols, reports, engineering standards, process descriptions, process specifications, and safety standards for all aspects of production. Develops or maintains engineering documentation for projects or facilities, e.g. Process flow diagrams, piping and instrument diagrams, material balances, specifications, data sheets and arrangement drawings. Trains manufacturing technicians in practical and theoretical aspects of process operations. Interfaces with outside contractors or technical consultants to solicit aid in problem solving or to oversee work performed by outside contractors. |
Requirements:
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A degree in Chemical Engineering and 3 to 6 years of pharmaceutical industry. API manufacturing experience is required. Performance at this level assumes an in-depth knowledge of process chemistry as well as engineering techniques sufficient to show independent design capability. Knowledge of specific techniques such as crystallization, chromatography, solvent recovery, and chemical synthesis. Knowledge of current state of the art of cGMPs. Knowledge of thermal hazard analysis of a chemical process and PLC controls is a plus. Working knowledge of PCs and MS office software. Expertise in spreadsheet and database creation and manipulation in order to assure data availability and accuracy. Effective business/scientific writing skills and ability to present scientific/engineering data orally to a wide variety of audiences. |
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