Lead Tech, Maintenance

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Health Savings Account with companys

Industry leading 401(k) savings plan

Insurance coverage

Employee assistance programs

Wellness incentives

Paid vacation time

Sick time

Company holidays

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a Lead Technician, Maintenance to oversee installation, maintenance, and repair of process systems in a GMP environment. The role requires leadership of a maintenance team and strong mechanical, electrical, and control-system knowledge.

The ideal candidate will perform preventive maintenance on bioreactors, centrifuges, ultrafiltration skids, autoclaves, isolators, and fillers, develop maintenance plans, and ensure compliance with FDA, CGMP

Qualifications

• Experience in maintenance for pharmaceutical/manufacturing environments.
• Knowledge of CGMP and safety standards.
• Experience with process equipment like bioreactors, autoclaves, isolators, and fillers.
• Strong leadership and mentoring abilities.

Responsibilities

• Lead a maintenance team through troubleshooting and repairs, PMs, and upgrades.
• Plan and perform preventive maintenance on process equipment and revise SOPs.
• Maintain maintenance records, forecast budgets, and support capital projects.
• Ensure compliance with safety, CGMP and regulatory requirements.

Skills

Mechanical systems

Electrical systems

Control systems

CGMP knowledge

Written and oral communication

Teamwork

Project management basics

Leadership

Multi-priority management

Training/mentoring

Education

High School Diploma/GED

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

Tools

CMMS

DeltaV training or similar process control system

BMS / Siemens / JCI training

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 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

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Prescription drug coverage
• Health Savings Account with company contributions
• Industry leading 401(k) savings plan
• Insurance coverage
• Employee assistance programs
• Various wellness incentives
• Paid vacation time
• Sick time
• Company holidays

Explore a supportive environment that enriches both your personal and professional growth!