Supervisor, Facilities Maintenance

Role Summary

The Supervisor, Facilities Maintenance will supervise and direct the facilities maintenance, calibration and metrology team; and manage the maintenance, preventive/corrective maintenance and upkeep of manufacturing and production assets for multiple locations. The role will participate in cross functional teams to ensure ImmunityBio’s expectations and standards are maintained.

Responsibilities

• Oversee and ensure all locations are maintained up to GMP standards and make recommendations for improving the maintenance, calibration, and safe use of equipment at multiple sites.
• Lead, coach, train and evaluate the performance of team members while directing the maintenance and calibration of facilities assets at multiple locations. Establish work schedules for the maintenance, metrology and calibration team.
• Interface with Senior Leadership and other stakeholders to plan and coordinate facilities preventative and corrective maintenance and provide progress reporting documents and briefing as required.
• Liaise with and oversee contractors‚Äô performance and take action to ensure compliance with all company standards and maintenance and calibration requirements, including sanitation, safety, quality, scheduling, productivity and budget. Ensure compliance with all required permits.
• Oversee, lead and perform preventive and corrective maintenance of critical plant equipment on a regular basis, to include, but not limited to, Manufacturing, Filling, Sterilization Equipment and electrical control systems as responsibility assigned to Manufacturing Maintenance in both cGMP and non-cGMP areas.
• Lead and delegate repairs and replacement of mechanical, electrical and controls components of Manufacturing, Sterilization and Packaging Equipment.
• Develop strategic plans for facility equipment maintenance, upgrades and acquisitions inclusive of participating in budgeting, cost estimation, and procurement processes.
• Collaborate with architects, contractors, and vendors on facility projects as needed.
• Troubleshoot, diagnose, and repair critical equipment including but not limited to plant equipment, filtration systems, centripetal equipment, pumps, sterilization, filling packaging equipment and electrical controls to include, but not limited to, indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems.
• Prepare maintenance reports, detail and document work order status.
• Prepare metrics reports, for facilities calibrations and metrology KPI.
• Lead engineering projects including but not limited to equipment installation, commissioning, and validation process. Ability to assist within the engineering group in equipment failure root cause analysis with prompt resolution.
• Create, maintain and adhere to Standard Operational Procedures (SOP), work plans, maintenance data templates, and drawing redlines as necessary.
• Oversee the maintenance of measurement data for the Measurement Data Template (MDT) and maintain metrics for reporting.
• Maintain documents in VEEVA.
• Ensure workplan templates are generated within computerized maintenance management system (CMMS) and resolves problems proactively as needed. Mentor and train new and junior team members.
• Lead and attend required training and meetings. Maintains training records for the team.
• Lead and participate in audits and regulatory inspections.
• Perform and delegate other special projects and duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Facilities Management, or a related field with 7+ years of Process GMP, Mechanical experience required; or 8+ years of Process GMP, Mechanical experience with a Maintenance Certificate or Utilities Certificate required; or High School Diploma with 10+ years of Process GMP, Mechanical experience required.
• 5+ years working experience of Computerized Maintenance Management Systems (CMMS) required.
• 3+ years‚Äô experience working in an FDA regulated environment required.
• Experience with and working knowledge of facilities equipment and preventive maintenance programs required.
• Critical Utility Systems (WFI, PUW, HVAC, waste neutralization, electrical generators, process utilities, etc.) required
• Supervisory and/or budget management experience preferred.
• Experience in a Pharma-Biotech manufacturing environment strongly preferred.

Knowledge, Skills, & Abilities

• Self-starter with the ability to work with minimum supervision.
• Excellent Instrumentation and mechanical skills and knowledge of maintenance principles.
• Ability to work in a fast-paced environment and maintain a high level of customer service.
• Hands-on execution of maintenance of process equipment, utility equipment, and facilities
• Working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant equipment.
• Follow and comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies.
• Ability to troubleshoot, diagnose, and repair of critical equipment including but not limited to plant equipment, filtration systems, centripetal equipment, pumps, sterilization, filling packaging equipment and electrical controls to include, but not limited to, indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems.
• Excellent written and verbal communication skills to effectively convey information in face-to-face and in group settings.
• Excellent teamwork and cooperation skills.
• Ability to lead a team and navigate the team through complex situations.
• Ability to understand and comprehend oral and written instructions.
• Able to work independently and make sound judgments regarding safety, work methods and tools
• Ability to multi-task and exercise good judgment.
• Proficient at understanding and writing reports and work instructions.
• Ability to understand the advanced process and control theory of a Critical or Major system.
• Able to demonstrate and maintain a positive attitude even during challenging tasks.
• Ability to verify mechanical and electrical drawings for accuracy as well as read wiring diagrams, blueprints and P&ID drawings.
• Able to understand and perform analog, digital, frequency, and time calibration of electronic systems and components.

Education

• As listed in Qualifications

Additional Requirements

• This position works on-site. Local travel required between ImmunityBio sites. Exposure to onsite in-lab environment. Must be able to don and wear Personal Protective Equipment (PPE) as required. Available to work off hours (weekends, holidays, after hours) to support company objectives. Ability to work in a standing position for long periods of time (up to 8 hours). Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position. Must be able to frequently lift up to 35 pounds and occasionally lift/move 50 pounds.