Sutro Biopharma, Inc. is looking for a Director of Engineering & Facilities experienced in facility and equipment design, and handling physical plant services to support Sutro’s cGMP facilities in San Carlos. You will be providing technical leadership for the engineering and maintenance needs including automation engineering, clean utilities, maintenance and calibration. The ideal candidate will have experience with Biotechnology equipment, centrifuge, fermenters, automation and control systems in a cGMP biologics manufacturing facility. Experience in creating and implementing systems for preventative maintenance and calibration is highly desired.
The Director of Engineering will be responsible for supporting operations in Sutro’s Biopharma’s cGMP Manufacturing Facility which will include:
• Design, start-up, commissioning, and qualification of new equipment
• Manufacturing strategy projects
• Process Improvement projects
• Management of GMP plant engineering/maintenance/Calibration
• Ability to perform gap analysis of the current maintenance, calibration, automation and alarm system and create strategy/plan to fill gaps
• Ability to work in a classified clean suite performing start up, troubleshooting or preventative maintenance on process and utility equipment.
• Identification and analysis of electrical or mechanical trouble of PLC computer controlled equipment and able to find lasting solutions so that the operations continuously improve reliability.
• Ability to author, edit and follow standard operating procedures.
• Manage and support EHS activities including waste management.
• Requires a Bachelor’s degree in engineering and a minimum of 10 + years of related experience in Pharmaceutical/Biotech operations, including thorough working knowledge of cGMPs, regulatory requirements, automation, and validation principles.
• Requires experience in Utility systems, including purified water, CIP, SIP, Compressed air and biological waste systems
• Experience in creating systems for preventative maintenance and calibration.
• Strong technical leadership, organizational planning, and project management skills
• Must have strong oral and written communication skills
• Must have strong interpersonal skills to help establish and maintain cross functional work environment.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.
Please submit resume for Req. #1319 to email@example.com. Please visit our website at www.sutrobio.com for more information. No relocation, local candidates (SF Bay Area)