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
  
  

The presently-anticipated base compensation pay range for this position is $74,000 to $82,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors