Engineer (Facilities & Engineering and Capital Projects)

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company: Bionova Scientific LLC Job Description: Bionova is seeking a motivated and innovative Engineer to serve in the Facilities and Engineering department. This role manages capital projects and serves as system owner for assigned clean utility systems and equipment. The position leads work from assessment, scope development, budgeting, and design through procurement, construction, commissioning, qualification support, turnover, and closeout. The role also sustains GMP facilities and equipment through troubleshooting, service coordination, equipment monitoring, annual shutdown execution, quality-system support, SOP revision, and continuous improvement. Onsite – M-F in Fremont, CA Some flexibility for hybrid can be arranged with manager approval Benefits Direct Hire Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%) Paid time off Annual Bonus eligible Essential Duties and Responsibilities: Manage capital projects for facility, laboratory, utility, infrastructure, and process-support equipment from initial assessment through closeout. Develop project scopes, option assessments, cost estimates, capital requests, budgets, schedules, risk assessments, and execution plans for new equipment and facility improvements. Develop or coordinate user requirements, engineering specifications, design reviews, RFPs, bid evaluations, procurement recommendations, and project documentation. Manage A/E firms, construction contractors, OEMs, service providers, RFIs, submittals, change orders, field coordination, startup, FAT/SAT, commissioning, and turnover activities. Monitor project scope, cost, commitments, forecast, schedule, risks, and changes; communicate status, decisions, constraints, and mitigation plans to stakeholders and leadership. Serve as system owner for assigned clean utility systems and related equipment, including performance monitoring, operational support, lifecycle planning, and technical decision making. Monitor equipment and utility performance; respond to alarms or adverse trends; coordinate troubleshooting, repair, service, and return-to-service activities. Define or support preventive maintenance, calibration, spare parts, vendor support, asset management, and improvement requirements for new and existing systems. Operate within GMP quality systems as record owner or subject matter expert for deviations, change controls, CAPAs, investigations, risk assessments, audits, and other quality records. Author, revise, review, and implement SOPs, work instructions, forms, specifications, drawings, and engineering standards for assigned systems and projects. Partner with Quality and Validation to support commissioning and qualification strategy, acceptance criteria, discrepancy res…

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