What are the responsibilities and job description for the Maintenance specialist position at Tek Support?
Responsibilities :
- Perform preventive maintenance and repairs on process equipment (bioreactors, ultrafiltration skids, autoclaves, isolators, fillers, etc.)
- Troubleshoot and resolve equipment malfunctions
- Support installation, commissioning, and validation of new equipment
- Develop and revise SOPs for process maintenance activities
- Maintain accurate documentation in compliance with GMP standards
- Assist in passivation, gasket replacement, and diaphragm seal changes for clean steam generators and bioreactors
- Adhere to safety requirements and report hazards to management or EHS
- Provide on-call support for emergency work orders as needed
Key Requirements :
Must-Have Experience :
- Maintenance of isolators, autoclaves, buffer prep, skids, and bioreactors in GMP environments
- Preventative maintenance and equipment repair
- Experience with utilities and process maintenance in GMP settings
Preferred Experience :
- Commissioning and validation experience
- FAT experience for facility expansions
Basic Qualifications :
- High School Diploma / GED
- 4 years of maintenance experience in GMP pharmaceutical or similar manufacturing settings
- Experience with Computerized Maintenance Management Systems (CMMS)
- Knowledge of mechanical, electrical, and control systems
Preferred Qualifications :
- Associate degree in Mechanical, Electrical, or Chemical Engineering
- 5 years of maintenance experience in GMP environments
- Relevant certifications (e.g., Certified Maintenance & Reliability Professional)
Last updated : 2024-11-25
