Lead Tech, Maintenance
Full-time
FUJIFILM Biotechnologies
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 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!
•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!
Vacancy posted 7 days ago
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