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Process Engineer

Company: Aerotek
Location: Thousand Oaks
Posted on: May 17, 2020

Job Description:

Ideal Candidate Must Haves: Biologics cell culture experience mainly Seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Thousand Oaks facilities. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The Engineer will apply cell culture process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in a new innovative manufacturing suite using single use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic single-use manufacturing facility. JOB RESPONSIBILITIES: Under guidance of Engineering staff, the associate engineer performs the following: - Transfers cell culture drug substance processes and performs process improvements from the laboratory into the manufacturing facility - Provides technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation - Offers process validation support for late stage commercial processes - Provides routine process monitoring and troubleshooting - Executes data trending and statistical process analysis - Supports technical direction for process related deviations (NCs), CAPAs and change controls - Identifies and supports process related operational excellence opportunities - Represents process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory BASIC QUALIFICATIONS: Masters degree OR Bachelors degree Associates degree and 7 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience PREFERRED QUALIFICATIONS: * Masters Degree in Chemical or Biochemical Engineering * 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities * Background in biologics tech transfer into commercial facilities * Upstream process knowledge: o Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes OR * Strong capability of analysis, troubleshooting and problem solving * Ability to develop and follow detailed protocols * Independently motivated with ability to multi-task and work in teams * Excellent written and verbal communication skills with technical writing and presentation experience About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing -- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Keywords: Aerotek, Thousand Oaks , Process Engineer, Engineering , Thousand Oaks, California

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