South San Francisco
- We are seeking for a senior chemical or mechanical engineer with more than 10 years of experience in the Biotech drug substance industry (large scale equipment, not filling, packaging or devices).
- Provide engineering and project management to capital and expense projects, including direction of other technical and contract personnel
- Participate in and/or lead engineering-related site or network improvement initiatives
- Provide engineering expertise and support to Technology, Manufacturing, Quality, and Facility Services on a variety of production equipment (including bioreactors, buffer prep and hold tanks, centrifuge, chromatography skids and columns, filtration equipment, CIP/SIP systems, parts washers, autoclaves, and bulk freeze/thaw tanks).
- Provide technical and procedural guidance to junior engineers
- Identify, analyze, and design improvements and capabilities for facility, utility, process, and equipment systems.
- Develop and maintain engineering documentation such as PFDs, P&IDs, design drawings and specifications, technical bid evaluation, vendor print reviews, design review, and protocols (FAT, SAT, and IQ).
- Support development and review project documentation such as schedules, budget, URS, PEP, RFQs, Contractor Bid Packages, Statements of Work, and Credit Applications.
- Drive and manage planning and design phases including project initiation and conceptual/basic/detailed design depending on assignment.
- Drive and manage FAT, SAT, commissioning, and installation qualification.
- Support debug, operational and performance qualification, and handover to operations.
- Act as Project Management on small projects.
- Manage construction phases including contractors, construction supervision, Genentech business processes, change orders, punch-list, turnover, and closure.
- Provide process/mechanical engineering expertise to support investigations, DMS, CAPA’s, audits, inspections, permits, and other technical requests.
- Collaborate with Global Engineering on major facility modifications, process expansions and new construction.
- Collaborate with peers in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.
- Bachelor of Science in Chemical Engineering, Mechanical Engineering or related Engineering.
- 7+ years of GMP manufacturing experience
- Experience with Engineering, Process Lead, Project Management, Engineering Change Control and other work processes and documentation in a GMP environment.
- Highly self-motivated, has excellent organization and communication skills, and is able to work independently or part of a multi-disciplinary team.
- Must be able to function in a team environment, interacting with various functional groups, as well as in a self-managed environment
- Ability to communicate information accurately and concisely, both verbally and in writing, to a diverse audience, in particular Manufacturing, Quality, SHE, Engineering Services, Facility Services, and Corporate Engineering
- Ability to produce high quality and accurate work in a timely manner
- Ability to develop into project engineering/management with associate processes and documentation.