Description
Responsible for maintenance and repair of cGMP production equipment, clean utilities and systems. Under minimal supervision conduct operation of facilities central plant and utility systems.
Job Responsibilities
Essential
Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
Make appropriate adjustments or modifications and notify supervisor of any abnormal parameters.
Collaborate with department teams to complete specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
Provide general labor services throughout all areas maintained by the Maintenance department.
Responsible for providing data to derive performance metrics for management, will be gathered on a daily basis for monthly reporting.
Provide general expertise and training to junior staff.
Ordering of spare and repair parts.
Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing equipment.
Cleaning and organization of designated work areas in Manufacturing and Utilities.
Complete GMP and other controlled documentation.
Will also revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
Interacts with Maintenance, Metrology and Engineering team members as well as manufacturing and other internal/external customers.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
Job Requirements
Education and Experience
High School graduate.
3 years general maintenance experience and minimum 1-3 years in a cGMP environment.
Knowledge, Skills and Abilities
Good communication skills, both written and oral.
Ability to learn and use Microsoft Windows based platforms and/or company Intranet.
Ability to use IBM based computer software applications (MS Word/Excel).
Ability to use Building Management Control System (BMCS).
Available to work overtime when necessary and work varying shifts, including an On-Call program.
General knowledge of shop tool operation and safety.
Ability to work independently.
Proven ability to work in a team environment.
Strong organizational and time management skills.
Work Environment/Physical Demands/Safety Consideration
Schedule may include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
Expected to be on feet for 8 to 10 hours a day.
May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
Climb heights up to 30 feet by ladder.
Lifting up to 40lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
May wear air purifying respirator and necessary hearing protection.
May crawl, kneel, stoop or work in small work spaces.
