Job Details
Date Apr, 21 2020
Position Engineer
Title Pilot Plant Senior Engineer
Location California, USA
Requirements Basic Qualifications: • Doctorate degree • Master’s degree and 3 years of engineering and/or manufacturing experience • Bachelor’s degree and 5 years of engineering and/or manufacturing experience • Associates degree and 10 years of engineering and/or manufacturing experience • High school diploma / GED and 12 years of engineering and/or manufacturing experience. Preferred Qualifications: • Bachelor’s degree in chemical, biochemical, mechanical engineering, or other relevant field • 5+ years of relevant work experience in a pharmaceutical/biopharmaceutical engineering role including 1+ years of experience in an operations/manufacturing environment. • Ability to demonstrate knowledge/proficiency in mammalian cell culture, recovery and/or protein purification. • Ability to read and understand engineering drawings (e.g. P&IDs, PFDs, GAs, Electrical Schematics) and ability to draft and develop P&IDs and PFDs. • Experienced with single use process systems. • Project support and design experience. • Knowledge of Lean Manufacturing principles. • Basic understanding of industry regulations and experience with regulated environments (e.g. cGMP, OSHA, EPA, ASME BPV, ASME BPE etc.). • Hands-on experience with manufacturing process equipment, including: advanced troubleshooting, reliability and performance improvements, and design optimization. • Leadership, technical writing, and communication/presentation skills. • Independent, self-motivated, organized, able to multi-task and change with adapting priorities in a fast-paced operational support environment. • Team player who is prepared to work in and embrace a team-based culture that relies on collaboration with peers and clients for effective results in a highly dynamic environment. • Experience with change control, process incidents/non-conformances, corrective and preventative actions, and commissioning and qualification practices. • Experience in engineering directly related to bulk biopharmaceutical production, including procurement and qualification. • Work schedule flexibility as needed to support process operations, requiring occasional after-hours or weekend coverage.
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