• 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.
• 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.