II: Essential Functions
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 call.
Monitor critical plant systems.
Perform daily meter readings.
Assist with trouble shooting of mechanical and electrical systems.
Perform planned and unplanned maintenance.
Work with and manage vendors.
Maintain records of building operations, repairs, parts and equipment.
Assist with the creation of Preventative Maintenance documents and Standard Operating Procedures.
Assist with writing Deviations, CAPAs, 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 / Biotech 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
HS Diploma/GED
Maryland Second or Third Grade Stationary Engineering License.
Universal CFC Refrigerant License preferred.
Prior experience working in a clean room preferred.
Prior experience with 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 preferred.
Must have the ability to multi-task and coordinate workload by priority.
Must be customer service and quality driven.
Prior cGMP experience preferred
Prior experience in an environment that implemented and maintained advanced maintenance techniques such as preventive and predictive maintenance programs (PMMS, TPM, Predictive Maintenance) preferred.
North Laurel, MD
