Provide support to the department management with regards to accomplishing tasks. Provide guidance and directives while working beside technicians to maintain a 130,000 Sq. Ft. Biotech Facility.
II: Essential Functions
Support the department management
Provide guidance and directives to Technicians
The individual will perform various duties as required to support 24/7 Plant and Process operations in a cGMP environment
Must be able to work 3:00- 11:00, 11:00-7:00 shift including some weekends
Must be able to respond to emergency on calls
Monitor critical plant systems
Perform system testing and meter readings
Perform planned and unplanned maintenance
Work with and manage vendors
Troubleshoots mechanical and electrical issues that may arise
Maintain records of building operations, repairs, parts, and equipment
Creation and execution of Preventative Maintenance documents and Standard Operating Procedures
Will write Deviations, CAPASs, Change Controls and SOP Revisions
Will assist in failure investigations (root cause) and help provide corrective/preventive actions to Deviations and equipment failures
Must comply with all applicable rules and regulations of the company and the pharmaceutical/biotechnology industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations such as the employee handbook.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
Maryland Third Grade Stationary Engineering License with Second Grade preferred
Prior clean room experience
Universal CFC Refrigerant License preferred
Prior experience in general utility systems, boilers, electrical, HVAC, and refrigeration systems
Prior experience with critical utility systems, purified water systems, clean steam, pharmaceutical gasses, classified HVAC systems
Must have the ability to multi-task and coordinate workload by priority
Must be customer service and quality driven
Prior cGMP experience
Prior experience in an environment that implemented and maintained advanced maintenance techniques such as preventive and predictive maintenance programs (Preferably SAP)
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