Full Job Description
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
3 Direct Hire
3 Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)
3 Paid time off
3 Annual Bonus eligible
Essential Duties and Responsibilities:
3 Manage capital projects for facility, laboratory, utility, infrastructure, and process-support equipment from initial assessment through closeout.
3 Develop project scopes, option assessments, cost estimates, capital requests, budgets, schedules, risk assessments, and execution plans for new equipment and facility improvements.
3 Develop or coordinate user requirements, engineering specifications, design reviews, RFPs, bid evaluations, procurement recommendations, and project documentation.
3 Manage A/E firms, construction contractors, OEMs, service providers, RFIs, submittals, change orders, field coordination, startup, FAT/SAT, commissioning, and turnover activities.
3 Monitor project scope, cost, commitments, forecast, schedule, risks, and changes; communicate status, decisions, constraints, and mitigation plans to stakeholders and leadership.
3 Serve as system owner for assigned clean utility systems and related equipment, including performance monitoring, operational support, lifecycle planning, and technical decision making.
3 Monitor equipment and utility performance; respond to alarms or adverse trends; coordinate troubleshooting, repair, service, and return-to-service activities.
3 Define or support preventive maintenance, calibration, spare parts, vendor support, asset management, and improvement requirements for new and existing systems.
3 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.
3 Author, revise, review, and implement SOPs, work instructions, forms, specifications, drawings, and engineering standards for assigned systems and projects.
3 Partner with Quality and Validation to support commissioning and qualification strategy, acceptance criteria, discrepancy resolution, and maintenance of the validated state.
3 Plan and lead the annual site shutdown, including scope collection, prioritization, integrated scheduling, vendor and resource coordination, execution control, startup, and closeout.
3 Provide day-to-day and, when required, after-hours technical support for critical project work, shutdown activities, and urgent facility, utility, or equipment issues.
3 Identify reliability, capacity, obsolescence, safety, and compliance risks and translate them into maintenance actions, improvement projects, or future capital plans. Other activities and duties as required or assigned.
Working Conditions:
3 This position requires work in office, manufacturing, warehouse, utility, mechanical, and lab settings.
3 The role requires walking, standing, stooping, kneeling, crouching, and climbing stairs.
3 The employee may occasionally lift and or move up to 40 pounds independently.
3 Occasional after-hours, weekend, or holiday work may be required for shutdowns, project cutovers, commissioning, or urgent system support.
Qualifications:
3 Bachelor's of Science degree in engineering or related technical discipline, or an equivalent combination of education and directly relevant experience.
3 Engineer level: typically at least 3 years of relevant engineering, facilities, utilities, equipment, or capital-project experience; GMP experience preferred.
3 Experience managing project scope, cost estimating, budgeting, scheduling, procurement, construction coordination, commissioning, turnover, and closeout.
3 Experience troubleshooting facility, utility, mechanical, controls, or process-support equipment and coordinating vendors and service providers.
3 Experience with GMP documentation and quality systems, including specifications, SOPs, deviations, change controls, CAPAs, investigations, and qualification support.
3 Excellent English verbal and written communication skills. Comfortable in a fast-paced, collaborative environment, managing multiple priorities with appropriate attention to safety, compliance, cost, schedule, and business continuity.
The base compensation range for this role is $95,000-$125,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.
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