Process Engineer / Sr. Process Engineer

Company OverviewImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. HistoryThe Company was founded in 1984 and in 1986, opened its laboratories at 180 Varick Street in New York City. In its early years, the Company focused on immunology-based diagnostics and infectious disease vaccines. This focus resulted in two FDA approved diagnostics and several vaccine research programs, all of which have been licensed to pharmaceutical companies. During the early nineties, the Company's focus shifted from diagnostics and infectious disease to the development of a pipeline of innovative, biologic compounds in the area of oncology. From this pipeline, three investigational monoclonal antibodies are being evaluated in various stages of clinical development. OperationsImClone Systems operates in two locations - its corporate and scientific headquarters at 180 Varick Street in New York City, which houses the Company's research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. This position is responsible for providing process engineering support for existing Clinical and Manufacturing operations, and/or future Manufacturing operations, and for the design, installation, start-up and validation of engineering work order (EWOK) projects and/or large capital projects for new Manufacturing facilities. 1. Support Clinical and Manufacturing operations through: a) equipment and process troubleshooting b) installation / modification of equipment or systems to optimize or improve existing operating procedures c) procurement of equipment and instrumentation as needed to support operations d) coordination with maintenance and metrology departments in managing the remediation of equipment and process issues e) development of all paperwork requirements (e.g., purchase orders, work orders, change control, NCE, etc.) as required 2. Provide process engineering support and/or project engineering management for EWOK projects($1MM), as necessary, which includes review of P&ID's, equipment arrangements, operating philosophy, equipment specifications, FAT's, construction, start-up and validation assistance.4. Ensure the integrity of company quality systems in the performance of all tasks, which includes compliance with such systems and self-management in obtaining sufficient and timely training. 1. Bachelor of Science, Engineering.2. 3 to 10 years industrial experience in a cGMP environment.3. Knowledge of /experience with biopharmaceutical processes and equipment, including bioreactors, centrifuges, TFF and chromatography systems, bioinactivation systems, media/buffer prep and CIP/SIP. Familiarity with cGMP's.4. Aggressive, take-charge, self-directed personality, with ability to work independently, self-sufficiently, and pro-actively in the performance of work duties. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2196104&boardid=749