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$87k–$97k/yr
Full-time
bachelor degree
Posted 42d ago
~40 hrs/week
Responsibilities
The role involves managing preventive and corrective maintenance for GMP-critical utilities and leading equipment validation efforts. Additionally, the engineer will oversee site infrastructure, support facility expansions, and ensure EHS protocol enforcement.
Requirements
Requires a Bachelor's degree in engineering or a related technical field with at least 5 years of experience in a GMP-regulated environment. Candidates must have solid knowledge of HVAC, BMS, and equipment qualification (IQ/OQ/PQ).
Full job description
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.
CDMO Services (Research, Development and cGMP Manufacturing for Biologics)
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2014
Headquarters
Fremont, California
LinkedIn followers
9,642
Bionova Scientific is a dynamic, full service, biologics Contract Development and Manufacturing Organization (CDMO) on a mission to deliver the highest quality process development and manufacturing services to biologic drug development companies around the world. Bionova’s renowned scientific expertise and dedication to its customers helps life changing therapies arrive to the market faster and more efficiently. At the heart of Bionova is a team of highly dedicated experts combining strong experience in cGMP biologics manufacturing and process development, with a technology-focused approach and a deep knowledge of the industry. From early stage research material generation to Process Development and GMP manufacturing, Bionova’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.
Offices: 3100 W Warren Ave, Fremont, California 94538, US
How much do Engineering jobs in The Woodlands, TX pay?
Based on 31 listings with disclosed salaries, most engineering jobs in The Woodlands, TX pay between $77k–$143k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in The Woodlands, TX right now?
There are currently 220 open engineering positions in The Woodlands, TX listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in The Woodlands, TX?
Companies currently hiring include Beusa Energy, ENTERGY ARKANSAS INC., Western Midstream, Webber, a Ferrovial company, Kodiak Gas Services, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in The Woodlands, TX?
Yes — 56 of the 220 open engineering positions offer remote or hybrid work (1 remote, 55 hybrid).
How do I apply for Engineering jobs in The Woodlands, TX?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.