Minimum 10 years of maintenance experience is a must!
The Maintenance Mechanic II performs preventative and corrective maintenance on manufacturing process related equipment such as agitators/mixers, dryers, centrifuges, reactors, chillers, cooling towers, air handler units, exhaust fans, autoclaves, blowers, valves, control panels, and various sanitary design pumps and valves within a cleanroom environment. The Maintenance Mechanic II troubleshoots, with minimal supervision, complex utility systems which may include Heating Ventilation and Air Conditioning (HVAC), steam boiler, electronic control systems, refrigeration, electrical, compressed air and gases, Reverse Osmosis (RO) water, waste water treatment, pure/clean steam, and/or other HPI/pharmaceuticals utilities.
The Maintenance Mechanic II also interprets drawings, layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. The Maintenance Mechanic II is involved in new equipment and plant systems installs as necessary.
DUTIES AND RESPONSIBILITIES
Operate in accordance and compliance with:
Current cGMP regulations and ICH Q7 guidelines
Work Rules, Quality Policies (QP), and Standard Operating Procedures (SOP)
Cardinal Rules of Quality, Delivery and Safety
Perform all of the duties and responsibilities of a Maintenance Mechanic I as needed in addition to those of a Maintenance Mechanic II
Perform monthly, quarterly, semi-annual, and annual Preventive Maintenance on both critical and non-critical mechanical, plumbing and electrical equipment
Perform on-demand maintenance, and advanced repairs on both critical and non-critical mechanical, plumbing and electrical equipment
Perform equipment and building rounds readings, and is responsible for identifying, mitigating, and reporting building system equipment malfunctions
Train Maintenance Mechanics (General and I) to successfully perform their jobs
Author accurate documentation for the operation and maintenance of various utility systems
Read and understand construction and machine blue prints, including machine drawings, building construction floor plans, P&ID diagrams, electrical drawings, schematics for pneumatic, gas supply, vacuum and high pressure piping systems.
Responsible for understanding the proper use of engineering and maintenance documentation, which is required under cGMPs. Examples include the Maintenance Work Order System, the Critical Change Request System, SOP documentation, Validation documentation, etc.
Open and close work orders using CMMS
Other duties as assigned
High school diploma or equivalent
A minimum of 3 years of experience in a food, beverage, or pharmaceutical processing environment required
Must possess general knowledge of the following skill sets: PLC, Electrical, Plumbing, HVAC, Welding, Pneumatic, Gas Supply, Vacuum, Writing/Revising SOPs, PM, cGMP
Strong communication and interpersonal skills
Must be customer service oriented
Ability to evaluate objectively, fairly, and consistently
Ability to use common hand and shop tools
Ability to understand and follow directions as given
Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant
Must be able to sit and/or stand for extended periods
Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
Must be able to lift 35 lbs. or occasionally lift up to 50 lbs