Lead Tech, Maintenance

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 135,000; Full time

Job summary

FUJIFILM Holdings America Corporation is seeking a Lead Technician, Maintenance to oversee the installation, maintenance, and repair of pharmaceutical processing equipment. You will lead a team, develop preventive maintenance plans, and ensure CGMP and OSHA compliance in a 2-2-3 shift pattern.

The role requires extensive maintenance experience, CMMS proficiency, and knowledge of DeltaV or similar control systems, with responsibilities spanning SOP development, budgeting support, and mentoring

Qualifications

• High School Diploma/GED
• 8+ years of maintenance experience
• CMMS experience
• DeltaV training or similar process control system
• BMS, Siemens, JCI, etc. training
• Preferred: Associate degree in mechanical, electrical, chemical engineering or related field
• Experience in pharmaceutical/manufacturing environment
• Experience in Project Management or Lean Six Sigma
• Experience leading or mentoring technicians
• Certified Maintenance & Reliability Professional/Technician or similar certification

Responsibilities

• Lead a team of Maintenance technicians to troubleshoot and repair equipment, perform preventive maintenance, and execute modifications/upgrades
• Plan and perform preventative maintenance on process equipment (bioreactors, centrifuges, ultrafiltration skids, autoclaves, isolators, fillers)
• Develop and implement preventive maintenance plans to minimize downtime
• Revise and develop SOPs for process maintenance activities
• Maintain accurate maintenance records and documentation
• Evaluate and select new equipment purchases and upgrades with management
• Assist in budget forecasting and capital project planning
• Ensure compliance with safety and CGMP quality standards
• Adhere to safety requirements and safe work practices
• Support site operations and emergency work orders during off-hours
• Perform spare parts assessments as required
• Provide training and mentoring to technicians

Skills

Mechanical systems

Electrical systems

Control systems

CGMP knowledge

CMMS experience

Leadership

Project management

Communication skills

Teamwork

Safety compliance

Education

Associate degree in mechanical/electrical/chemical engineering or related field

Job description

Position Overview

The Lead Technician, Maintenance is responsible for the installation, maintenance, and repair of process related systems and equipment. This includes ensuring the associated systems meet the stringent requirements of pharmaceutical manufacturing. The Lead is also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime while complying with all applicable regulatory requirements, including Food & Drug Administration (FDA), Current Good Manufacturing Practice (CGMP), and Occupational Safety and Health Administration (OSHA).

This position is a 2-2-3-day shift 12 hours. 6am-6pm

Job Description

What You'll Do

• Leads a team of Maintenance technicians through troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing equipment modifications and upgrades
• Plans and performs preventative maintenance and repairs on process equipment, such as bioreactors, centrifuges, ultrafiltration skids, parts washers, autoclaves, isolators, and fillers
• Develops and implements preventative maintenance plans to minimize equipment down time
• Revises and develops Standard Operating Procedures (SOPs) for process maintenance related activities
• Maintains accurate maintenance records and documentation
• Evaluates, recommends, and selects new equipment purchases and upgrades with management
• Assists and provides recommendations to management to develop and maintain the maintenance annual budget and schedule requirements
• Participates in budget forecasting for maintenance and capital projects
• Follows SOPs and protocols to ensure compliance with safety and CGMP quality standards
• Adheres to all safety requirements and follow safe work practices
• Notifies management or Environmental Health & Safety (EHS) when unsafe conditions or hazards are found
• Attends all required and safety and health training
• Supports site operations and emergency work orders during off-hours, as needed
• Performs spare parts assessments, as required
• Provides training and mentoring to other technicians
• Performs other duties, as assigned

Knowledge & Skills

• Advanced knowledge of mechanical, electrical, and control systems
• Strong knowledge of CGMP requirements
• Effective communication, both written and oral
• Ability to work in a team environment
• Knowledge of Project Management principles
• Strong leadership and problem-solving skills
• Ability to manage multiple priorities
• Strong time management skills and detail-oriented
• Ability to train or mentor others

Basic Requirements

• High School Diploma/GED
• 8+ years of maintenance experience
• Experience with Computerized Maintenance Management System (CMMS)
• DeltaV training or similar process control system
• BMS, Siemens, JCI, etc. training

Preferred Requirements

• Associate degree in mechanical, electrical, chemical engineering or a related field
• Prior maintenance experience in a pharmaceutical or manufacturing environment
• Experience in Project Management or Lean Six Sigma
• Experience leading or providing oversight to technicians in a pharmaceutical or similar manufacturing environment
• Certified Maintenance & Reliability Professional, Certified Maintenance & Reliability Technician, or certification in another relevant field

PHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection. No X YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X YesWill work in environment operating a motor vehicle or Powered Industrial Truck. No Yes XAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. No X Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to sit for prolonged periods of time. No X Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes ENVIRONMENTAL CONDITIONSWill work in warm/cold environments. No X Yes 0-115F Range (If yes, specify approximate temperature ranges.)Will work in outdoor elements such as precipitation and wind. No X YesWill work in small and/or enclosed spaces. No X YesWill work in heights greater than 4 feet. No X Yes

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading401(k) savings plan, insurance coverage, employee assistanceprograms and various wellness incentives. We support life-work balance withpaid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!