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Engineer
3 weeks ago
Description:
ONSITE THOUSAND OAKS
Flexible availability, schedule is 7am - 4pm need to be open to afterhours calls.
Preferred Qualifications:
Bachelor's degree in chemical or mechanical engineering
4+ years of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Basic Qualifications
Master's degree or bachelor's degree and 2 years of experience OR associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Top 3 Must Have Skill Sets:
Troubleshooting skills
Mechanical systems expertise
Ability to analyze problems, develop and propose engineering solutions in a scientific manner
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