- Expired: over a month ago. Applications are no longer accepted.
- Comply/adhere with cGMP regulations, policies, SOPs and batch records
- Assist the Validation department with the operation and execution of engineering projects related to all phases of the lyophilization process.
- Under the supervision of the Sr. Manager Facilities and Lyophilization Supervisor, installs, maintains, operates repairs and troubleshoots low-temperature refrigeration systems.
- Installs, maintains, overhauls, and operates refrigeration equipment including compressors, pumps, evaporators, expansion valves, solenoid valves, all controls, condensers, and other related components.
- Focus on process improvement throughout the manufacturing and packaging areas.
- Coordinate and perform preventive/reactive maintenance on lyophilization equipment.
- Maintains detailed maintenance and spare parts records.
- Coordinates contracted maintenance activities with vendors.
- Assists in qualification of equipment/facilities as needed.
- Compiles, analyzes, draws conclusions, and provides written documentation related
to the maintenance and lifecycle of production systems.
- Administers project management controls and reports status to senior management.
- Involved in the oversight and coordination of activities that include design,
specification creation, procurement, construction management, repair of production
and facilities equipment.
- Utilizing the Building Automation Systems (BAS) monitors lyophilization systems,
manufacturing and laboratory environments, refrigeration units, incubators, etc.
- Operates BAS terminals to monitor, trouble shoot, and maintain applicable system
performance consistent with required unit and/or area conditions, following all
change control procedures.
- Ability to read PID drawings. Control schematics; ability to analyze refrigeration
problems and take corrective action; ability to upload and download programs and
utilize computer-based Building Automation Systems for trouble shooting and
monitoring system performance.
- Assignments are broad in nature, requiring originality and ingenuity, and rely on
collaboration, limited experience, and judgment to plan and accomplish goals
- Assists in programming, maintenance and troubleshooting of programmable logic
controllers and process/environmental monitoring systems.
- Establish procedures with some supervision.
- Performs equipment calibrations.
- The above statements are intended to describe the general nature of work performed by those in this job.
AddressMontgomery Village, MD
Sports and RecreationView all jobs at Medix
Get fresh Validation Specialist jobs daily straight to your inbox!
You Already Have an Account
We're sending an email you can use to verify and access your account.
If you know your password, you can go to the sign in page.