Lead Tech, Maintenance

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Health Savings Account (HSA)

Employee assistance program

Wellness incentives

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Lead Technician, Maintenance to lead a team in installing, maintaining and repairing process equipment used in pharmaceutical manufacturing. You will oversee preventive maintenance on bioreactors, centrifuges, and sterilization systems, ensuring CGMP compliance and minimal downtime.

The role requires 8+ years of maintenance experience, CMMS and DeltaV training, strong leadership, and the ability to develop maintenance SOPs, manage

Qualifications

• 8+ years of maintenance experience in manufacturing or pharmaceutical environments.
• Experience with CMMS and process control systems (DeltaV or equivalent).
• Strong CGMP knowledge and adherence to safety standards.
• Ability to develop SOPs for maintenance activities.
• Proven leadership and mentoring capabilities.

Responsibilities

• Lead a team of maintenance technicians in troubleshooting, preventive maintenance, and equipment upgrades.
• Plan and perform maintenance on bioreactors, centrifuges, ultrafiltration skids, autoclaves, isolators, and fillers.
• Develop maintenance plans to minimize downtime and improve reliability.
• Maintain maintenance records and documentation; revise SOPs as needed.
• Participate in budget forecasting and capital project planning; manage vendor relations.

Skills

Mechanical

Electrical

Control systems

CGMP knowledge

Leadership

Teamwork

Communication

Project management

Education

High School Diploma/GED

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

Tools

CMMS

DeltaV

Siemens/Johnson Controls training

Job description

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 Requirements

PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No Yes X
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability 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 Yes
Ability to operate machinery and/or power tools. No X Yes
Ability 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 CONDITIONS
Will 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 Yes
Will work in small and/or enclosed spaces. No X Yes
Will work in heights greater than 4 feet. No X Yes

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust 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 leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!