Plant Services Specialist

2 weeks ago

Billerica, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

This is a 2nd shift position, with an additional 10% shift differential for all 2nd shift hours worked. The successful candidate will 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.

Key Responsibilities
  • Develop and maintain records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
  • Manage execution of PMP programs consistent with cGMP engineering maintenance requirements
  • Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
  • 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 to complex problems related to equipment or process
  • Perform equipment, utility, and plant validation as needed
  • Review and update maintenance SOPs for plant, equipment, and utilities
  • Follow all company policies related to job safety
  • Troubleshoot manufacturing equipment/plant/utility problems
  • Support operations improvement and maintenance projects
  • Perform improvements and maintenance as required to support all operations
  • Support validation maintenance program
  • Execute validations for manufacturing equipment and processes as needed
  • Maintain records for operations plant, equipment, and utilities
  • Monitor steam utility per MA State requirements
  • Maintain records for waste water requirements
  • Manage janitorial services and plant waste stream
Work Conditions

The successful candidate will work in a variety of environments, including office, lab, and shop/shipping areas. Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits is expected.

Requirements
  • 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
  • Electricians license preferred
  • Ability to plan, prioritize and organize diversified workload
  • Familiarity with use of computers and MS Office
  • 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 Firemans License preferred
  • Pharmaceutical industry experience
  • Formal cGMP training
  • Experience reviewing/updating Standard Operating Procedures
  • Experience maintaining operation records

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