Title:  Manufacturing Maintenance Specialist II

Job Summary

Manufacturing Maintenance Specialist II support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.

Area Of Responsibility

• Participates in maintaining records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
• Supports maintenance programs consistent with cGMP engineering maintenance requirements
• Interact with and direct vendors for manufacturing improvement (i.e Clean utilities, and manufacturing equipment)
• Perform non-routine and off-hours tasks as necessary
• Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
• Solve simple problems related to equipment or process
• Support equipment, utility, and plant validation as needed
• Follows  maintenance SOPs for manufacturing and critical system  equipment, and utilities
• Follow all company policies related to job safety
• Work with supervision using some standard procedures as well as troubleshooting and decision making
• Participates in the troubleshooting of manufacturing equipment and critical utility problems
• Support operations improvement and maintenance projects
• Participates in improvements and maintenance as required to support all operations
• Support validation maintenance program
• Supports the execution of validations for manufacturing equipment and processes as needed
• Maintain records for manufacturing equipment, and critical systems
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Shop/shipping areas
• Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
• Close, distance and peripheral vision; depth perception, ability to focus
• Ability to operate production equipment and hand tools
• Operate hand truck
• Operate company truck
• Current, valid Driver's license
• Operate computer/office machines
• Wear Safety shoes, safety glasses, gloves
• Lift up to 70 lbs.
• Ability to work a flexible schedule

Travel Estimate

Up to 5%

Education and Job Qualification

• High school diploma or equivalent required

• Technical certification preferred
• Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
• Knowledge of aseptic techniques
• Ability to read & create engineering drawings
• State boilers “Special License to Operate” preferred
• Electrician’s license preferred
• Ability to plan, prioritize and organize diversified workload
• Familiarity with use of computers and MS Office

Experience

Required:

• Minimum 2+ years related experience required, preferably in the pharmaceutical industry

• Experience with Building Automation Systems
• HAZMAT training
• Proficient with use of hand tools and power equipment
• Demonstrated mechanical ability
• Willingness and ability to obtain Boiler Specialist License required; Current Fireman’s License preferred

Preferred:

• Pharmaceutical industry experience
• Formal cGMP training
• Experience reviewing/updating Standard Operating Procedures
• Experience maintaining operation records