Pharmaceutical Facilities Specialist (2nd shift 12:30pm - 9pm) - Kaztronix
Billerica, MA 01821
About the Job
Pharmaceutical Facilities Specialist
(2nd shift 12:30pm - 9pm)
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
Other duties as assigned
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” or higher preferred / obtain within 6
months of employment)
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
(2nd shift 12:30pm - 9pm)
Job Summary
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
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)
Serve as Support for Manufacturing equipment and processes (i.e LYO, Filling, mixing, autoclaves, washers, granulators, label, packaging and inspection)
Serve as support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
Support Plant Services and Manufacturing teams in cleanroom environments
Perform improvements and maintenance activities in cleanroom environments
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
Work with supervision using some standard procedures as well as troubleshooting and decision making
Troubleshoot manufacturing equipment/plant/utility problems
Support operations improvement and maintenance projectsSupport 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
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)
Serve as Support for Manufacturing equipment and processes (i.e LYO, Filling, mixing, autoclaves, washers, granulators, label, packaging and inspection)
Serve as support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
Support Plant Services and Manufacturing teams in cleanroom environments
Perform improvements and maintenance activities in cleanroom environments
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
Work with supervision using some standard procedures as well as troubleshooting and decision making
Troubleshoot manufacturing equipment/plant/utility problems
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
Other duties as assigned
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” or higher preferred / obtain within 6
months of employment)
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
Source : Kaztronix
