The Principal Engineering Manager – Reliability Engineering at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Director of Engineering. This position is being established to provide the maintenance and reliability strategy for the department with direct accountability for ensuring equipment/process uptime through management of key metrics (MTTR, MTBF, OBE, OEE) and continuous improvement.  In addition, support will be required for maintenance and optimization of the process and equipment across drug substance, drug product and general operational areas. The role combines both a hands-on approach along with leadership skills to perform troubleshooting of equipment, root cause analysis, component and system analyses to identify reliability improvements and reduce risks with design modifications and/or various reliability improvement strategies. Responsibilities may also involve leading process improvements through change control procedures, implementing corrective and preventive actions via the CAPA system and guiding equipment commissioning/qualification.

Essential Functions:

• Develop Standard Operating Procedures (SOPs) that define maintenance strategy, reliability engineering, preventative maintenance (PM) and condition-based maintenance (CBM) while collaborating with calibration and maintenance teams.
• Collect data and report on equipment/process efficiency metrics (OBE, OEE, OA).
• Lead and implement initiatives for equipment/process uptime, including data collection, analysis, parameter changes, etc.
• Review, assess and share all areas of maintenance impact on new and modified installations.
• Perform Failure Modes and Effects Analysis (FMEAs) for new and existing assets.
• Establish asset criticality, determine maintenance, repair and operations (MRO)/spare parts requirements, quantities and order points.
• Apply value analysis to determine repair or replacement decision.
• Use Root Cause Analysis (RCA), failure analysis and other applicable methodologies to improve equipment reliability, including corrective design changes and implementing maintenance strategy modifications. 
• Provide framework and training to technicians for the predictive maintenance program, including thermography, vibration, ultrasonic technologies, life-cycle cost analysis and equipment installation requirements.
• Perform preventative maintenance optimization.
• Analyze equipment failures to determine root cause and implement corrective actions.
• Collaborate with Operations and Manufacturing Science and Technology (MSAT) on process and equipment updates to increase reliability.
• Evaluate and implement new technologies for enhanced equipment reliability.
• Understand the manufacturing equipment/processes on the impact of equipment performance within the manufacturing system.
• Prepare necessary material and conduct training to technicians and engineers.
• Promote proper use of the computerized maintenance management system and ALCOA+ principles for developing maintenance strategies, execution and documentation.
• Request and update capital funding requests to maintain assets.

• Provide strategic oversight of engineering activities, troubleshooting support and technical expertise for process equipment and site utilities.
• Support client, quality, and regulatory audits and inspections.
• Lead and manage new equipment/systems installation, including infrastructure, connectivity, and capability assessments.
• Lead and train direct reports in developing change controls for the implementation of new system/equipment installations, process improvements, and site utilities.
• Liaise with the CAPEX team for the implementation of capital projects.

• Perform all other duties as assigned.

Required Skills & Abilities:

• Employ a hands-on approach with problem solving independently or through facilitation with other engineers, technicians, trades, etc. This may include analysis of failed machine tool components such as motors, pumps, gearboxes, etc.

• Collaborate effectively with contractors, manufacturing and quality.
• Communicate efficiently with both internal and external stakeholders.
• Support proper testing, validation, and compliance with regulations.
• Develop and review SOPs and maintenance procedures.
• Ensure compliance with cGMP, FDA, and EHS guidelines.
• Maintain a safe work environment and adhere to safety protocols.
• Demonstrate leadership and mentorship skills.
• Identify and solve engineering problems efficiently.
• Manage multiple projects and priorities effectively.
• Proficient in project management software and MS Office Suite.
• Strong analytical and problem-solving abilities.
• Communicate technical information clearly to various audiences.
• Self-motivated and adaptable in fast-paced settings.
• Pursue continuous improvement and learning.
• Knowledge of biomedical/biotechnical equipment and regulatory standards.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
• Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.
• Regularly lift and move objects weighing up to 50 pounds.
• Climb ladders and stairs of varying heights.
• Work under conditions that may be wet or humid.
• Provide support during off shifts, weekends, and holidays as needed.
• Work in outdoor weather conditions and noisy environments.
• Offer 24/7 support for company activities.
• Maintain mandatory attendance.

Minimum Qualifications:

• Bachelor’s degree in engineering with ten (10) to fourteen (14) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR
• Master’s degree in engineering with eight (8) to twelve (12) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
• A minimum of four (4) or more years of previous leadership experience.

Preferred Qualifications:

• Knowledge of bio-processing equipment, clean utilities, and single use equipment.
• Knowledge of quality management software
• Knowledge of both upstream and downstream drug substance processes including drug product operations.
• Certified Maintenance & Reliability Professional (CMRP) and/or Certified Reliability Engineer (CRE) Certification.
• Engineering degree preferably in Mechanical, Chemical, Electrical or Biomedical Engineering.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.