Apply on Employer Site

FUJIFILM Biotechnologies · 7 hours ago

Sr Manager, Facilities Maintenance

College Station, TX

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

FUJIFILM Biotechnologies is seeking a Senior Manager of Facilities Maintenance to oversee day-to-day operations, maintenance strategies, and vendor management. The role involves ensuring compliance with safety and quality standards while managing a team responsible for facility and utility operations, including equipment maintenance and emergency response.

BiotechnologyHealth CareManufacturing

Responsibilities

Responsible for taking a leadership role in the day-to-day operations of the maintenance group, able to handle multiple priorities quickly and efficiently and delegating tasks to appropriate trades and skill levels

Responsible for evaluating, developing, scheduling and /or conducting training to facilities, utilities and /or maintenance personnel about new or existing equipment /systems and ensure such training is reflected in current SOPs and other procedures (PMs, Calibrations, etc.) as required

Support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable

Responsible to respond and support outages and plant-wide emergencies

Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required

Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDP

Maintain regular communication with production and support area counterparts to ensure planned maintenance activities are executed effectively and any issues are addressed promptly

Communicate effectively with Contractors, Validation, Quality Assurance, Quality Control, Operations, Engineers, OEM providers, as well as internal equipment owners and operators, for successful management of the facilities department in FLBT

Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility

Able to work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/or maintained as prescribed

Develop, implement, maintain, and monitor departmental KPIs to ensure a high level of efficiency

Responsible for all Facilities/Utilities areas SOPs, PMs, JHA’s

Ensure departmental cGMP compliance by staying current with assigned SOPs, maintaining up-to-date training files, and meeting all mandatory training requirements, including ADP courses

Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, and site procedures

Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities

Maintain a positive, professional, and customer-oriented attitude

Hire, train, develop and evaluate maintenance operations staff. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with the Director of Facilities and Human Resources as appropriate

All other duties as needed

Qualification

CGMP knowledgeTechnical troubleshootingPreventative maintenanceRegulatory complianceLeadershipMS OfficeChange Control managementTraining developmentCommunication skillsOrganizational skills

Required

Bachelor's degree in a maintenance/facilities or related discipline with a minimum of eight (8) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency, OR

Associate's degree in a maintenance/facilities or related discipline with a minimum of ten (10) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency, OR

High school diploma or general education degree (GED) in a maintenance/facilities or related discipline with a minimum of twelve (12) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency

A minimum of five (5) or more years of previous leadership experience

Strong leadership qualities and skills

Strong understanding of plant and clean utilities system operation and applicable cGMP requirements with the ability to instruct and guide others on those requirements

Strong understanding of cGMP requirements and design for clean rooms including HVAC pressure cascades, pressurization, room air changes and environmental controls

Strong technical troubleshooting / problem solving skills. Possess or could gain knowledge with respect to the operation and maintenance of various utilities / process systems and be able to transmit all this knowledge to direct reports and peers

Knowledge of a wide variety of typical maintenance tasks including corrective maintenance, troubleshooting systemic problems and the tools and equipment required to perform these maintenance tasks

Knowledge using blueprints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgement when taking corrective actions during equipment malfunction

Must be able to generate and manage Change Controls and perform Deviation investigations

Must be able to develop clear procedures for equipment, utilities and maintenance operations

Knowledge of NFPA 70E requirements for safe work practices and be able to guide direct reports and contractors in such requirements

Knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements and be able to guide direct reports and contractors in such requirements

Knowledge and understanding of OSHA regulations, and safe work practices

Strong written, verbal and interpersonal communications skills

Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility

Ability to work quickly and effectively without constant supervision. Ability to lead a combination of 10 + maintenance supervisors / skilled technicians in support of facility maintenance

Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint)

This role will require a high level of personal organizational skills, experience, and drive. The successful candidate must have a vision of a final state, fully organized Facilities Maintenance department in a highly regulated GMP environment

Knowledge of preventative maintenance development using a GMP Computerized Maintenance management System (CMMS) required

Preferred

Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS

Knowledge of Trackwise quality management software

Knowledge of bio-processing equipment, and single use technology

Experience with development of technician training / qualification program

A wide range of maintenance and trade experience is a plus, including mechanical /electrical systems, variable frequency drives, pumps, electric motors, and PLC operations