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Job Order Date 3/7/2008
Job Title Process Development Engineer JP0310
Job ID JP0310
Responsibilities Our client is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness by developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care.
With 70 years of service to the hospital industry, the portfolio includes one of the industry`s broadest lines of generic acute-care and injectables, and integrated solutions for medication management and infusion therapy. Company is also a leading provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies for formulation development, filling and finishing of injectable pharmaceuticals. The environment is casual with a strong desire to be successful. Beautiful location North of Denver.

Experience:
BS in Chemical Engineering with 5 years of pharmaceutical industry (or similar) experience. API experience highly desired but try fine chemicals with cGMP experience. 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. 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.

This position will report into the Manager of API Development in the R&D department and will work closely with the Scientists in the development and transfer to new API development into manufacturing.
In this role you will oversee a variety of projects and must be flexible with a desire to achieve. The environment is fast paced and with accountability in meeting specific goals and objectives. You will spend a majority of time on scale up work from lab through pilot plant to manufacturing.
Major Responsibilities:
Act 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
Develop and recommend new process improvements and new technologies to achieve cost effectiveness and improve product quality
Establish operating equipment specifications and recommend improvements to manufacturing techniques
Participate in new product scale-up, process development and optimization, technology transfer and process validation activities
Interface 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
Draft SOPs to document new process procedures or writes revisions to recognize changes through optimization or technology change
Develop or maintain engineering documentation for projects or facilities
Train manufacturing technicians in practical and theoretical aspects of process operations
Interface with outside contractors or technical consultants to solicit aid in problem solving or to oversee work performed by outside contractors
Assist manufacturing operations staff with problem solving and troubleshooting when process or equipment difficulties arise
Improve safety conditions of complex systems or processes, for reducing waste, and for support of environmental compliance

Requirements
City Denver
State or Prov CO
Min Degree BS
Major ChemE
High Salary 90000