Facility and Validation Engineer

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 Scientific an Asahi Kasei company is seeking a motivated, hands-on, and technically skilled Facility and Validation Engineer to join our growing Facilities & Engineering (F&E) team. As part of the F&E group, you will support facility operations across GMP manufacturing, Development and Quality control laboratories, and utility systems and play a critical role in capital expansion, qualification, validation, and EHS program implementation. This role provides a unique opportunity to gain broad exposure to Advanced Therapies operations—including engineering design, equipment qualification, clean utility management, and cross-functional collaboration to enable successful GMP execution and facility growth, that ultimately improve patient outcomes. Location: The Woodlands Texas Company Summary: Bionova Scientific is a rapidly growing, biologics and plasmid DNA manufacturing 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. Essential Duties and Responsibilities: GMP Manufacturing Facility Support Perform, manage or oversee preventive and corrective maintenance on GMP-critical utilities: HVAC, compressed gases, cryogenics, cleanroom systems, etc. Lead or support equipment validation efforts, including protocol generation, execution, and final report compilation. Monitor and maintain environmental conditions (temperature, RH, pressure) via BMS/EMS systems to ensure GMP compliance and audit readiness. Monitor critical parameters (e.g., temp, RH, DP) using BMS/EMS systems; respond to deviations and maintain control environments per Annex 1 and FDA expectations. Maintain and improve calibration and PM programs, using CMMS to track assets, work orders, and compliance records. Own or support commissioning, qualification (IQ/OQ/PQ), and validation for process equipment (FAT/SAT). Own or support commissioning, qualification (IQ/OQ/PQ), and validation for clean utilities (e.g., WFI, RO/DI, HVAC, BSCs, autoclaves) in accordance with GMP and validation protocols. Ensure adherence to cGMP and GDP standards across all documentation and facility operations. Act as SME or system owner for designated utilities or equipment. Support audits, deviations, CAPAs, and change controls. Facilities Operations and Infrastructure Oversee maintenance of site infrastructure electrical, plumbing, fire safety, lighting, structural, and automation systems. Monitor Building Management Systems (BMS), respond to alarms, and support utilities integration. Coordinate and supervise contractor/vendor activities ensuring adherence to GMP, EHS, and internal SOPs. Manage small facility projects (e.g., room upgrades, equipment installations, relocations). Ensure spare parts, tools, and critical consumables are tracked and available to minimize client and internal programs downtime. Project Engineering and Strategic Initiatives Participate in facility expansions, renovations, or lab buildouts; provide specifications and design input. Interface with architects, engineers (A&E), and construction teams to provide input on design specifications and user requirements. Lead or assist in implementation of automation, asset management systems (CMMS, Historian), and clean utility projects. Support equipment selection, procurement, FAT/SAT, and onboarding to operational readiness. Drive operational excellence through data-driven analysis, process optimization, and cross-functional engagement. EHS Support & Compliance Support implementation and enforcement of Environmental, Health, and Safety (EHS) protocols in labs, GMP suites, mechanical spaces, and contractor-managed areas. Conduct or assist in EHS risk assessments, inspections, and incident follow-up activities. Ensure all facility work is conducted safely, using LOTO procedures, PPE, and applicable permit systems. Working Conditions: Role will involve working across GMP cleanrooms, mechanical spaces, laboratories, and general office areas. May require off-hours support or weekend availability during project execution or shutdowns The role requires walking, standing, stooping, kneeling, and crouching. The employee may occasionally lift and or move up to 40 pounds independently. Qualifications: Bachelor’s degree in engineering, Facilities, or related technical field (or equivalent experience). Minimum 5 years of experience in facilities engineering, maintenance, or operations in a GMP-regulated environment. Solid knowledge of facility systems: HVAC, BMS, EMS, cleanrooms, electrical, plumbing, and water systems. Experience with equipment qualification (IQ/OQ/PQ) and validation of process/lab equipment under cGMP. Experience with CMMS and GMP documentation systems. Familiarity with FDA, EU Annex 1, ISPE Baseline Guides, and industry EHS best practices. Excellent troubleshooting, problem-solving, and technical communication skills. Demonstrated ability to manage vendors, projects, and maintenance programs. Able to lift up to 50 lbs and work in varied environments (mechanical rooms, rooftops, cleanrooms). Strong organizational skills and ability to multitask across priorities in a fast-paced setting. Able to work in mechanical rooms, cleanrooms, and elevated spaces; capable of lifting up to 50 lbs as needed. The base compensation range for this role is $87,000-$97,000. 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. #LI-MG1 As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to View email address on click.appcast.io. Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account.