Top 14 Facility and validation engineer Jobs in Montgomery Tx

Facility and Validation Engineer
Bionova Scientific LLC —The Woodlands, TX
- $87,000 - $97,000 a year
- Weekends as needed
- 5 years
- Engineering
- Data analysis skills
2d
Facility and Validation Engineer
Asahi Kasei —The Woodlands, TX
- $87,000 - $97,000 a year
- Weekends as needed
- 5 years
- Engineering
- Data analysis skills
2d
Validation Engineer
Cellipont Bioservices —The Woodlands, TX
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
- Paid holidays
- Tuition reimbursement
Quick Apply
11d
Project Engineer
Entergy Corporation —The Woodlands, TX
- Overtime
- Up to 50% travel
- Bachelor of Science
- Engineering
Lead Computer Systems Validation (CSV) Engineer (W)
Cellipont Bioservices —The Woodlands, TX
- Full-time
- Computer Science
- Bachelor of Science
- Continuous improvement
- Paid holidays
- Tuition reimbursement
Quick Apply
11d
Project Engineer
ROI Agency —The Woodlands, TX
- Up to 50% travel
- Bachelor of Science
- Engineering
Quick Apply
8d
AI Quality Assurance Specialist Sr. Lead
Entergy Corporation —The Woodlands, TX
- Overtime
- Hybrid work
- Computer Science
- Writing skills
- Mid-level
14d
Data Engineer III
Beusa Energy, LLC —The Woodlands, TX
- Full-time
- Background check
- Computer science
- 7 years
Project Engineer - Sr. Staff
ROI Agency —The Woodlands, TX
- Up to 50% travel
- Bachelor of Science
- Engineering
Quick Apply
8d
Systems Solutions & Adoption Lead
Moffatt & Nichol —The Woodlands, TX
- Full-time
- Background check
- Computer science
- 7 years
- Wellness program
- Health savings account
Quick Apply
Manager, Power Development
Entergy Corporation —The Woodlands, TX
- Overtime
- Bachelor of Science
- Engineering
- Continuous improvement
Engineer Logistics Solutions 2
DAIKIN COMFORT TECHNOLOGIES MFG INC —Waller, TX
- Computer science
- Microsoft Outlook
- Computer Science
Quick Apply

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Facility and Validation Engineer
Bionova Scientific LLC —The Woodlands, TX
Bachelor's degree in engineering, Facilities, or related technical field (or equivalent experience). Support implementation and enforcement of Environmental,…
$87,000 - $97,000 a year
2d
Facility and Validation Engineer
Asahi Kasei —The Woodlands, TX
Bachelor’s degree in engineering, Facilities, or related technical field (or equivalent experience). Support implementation and enforcement of Environmental,…
$87,000 - $97,000 a year
2d

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Facility and Validation Engineer

Bionova Scientific LLC -
The Woodlands, TX

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Job Details

Full-time
$87,000 - $97,000 a year
2 days ago

Qualifications

Manufacturing plant facilities maintenance experience
HVAC control system operation
Environmental compliance
Equipment troubleshooting
GMP
Cleanroom protocols
Project management experience in manufacturing
Electrical systems facility management
Manufacturing facility experience
Production validation processes
Water systems
Cleanroom experience
Technical troubleshooting support
Mechanical troubleshooting
Pharmaceutical manufacturing facility experience

Full 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.

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facility and validation engineer jobs in montgomery tx

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