Maintenance Mechanic 1st Shift
New Brunswick, NJ US
Maintenance mechanic. W/ pharma experience.
Maintenance of pharmaceutical manufacturing plant/equipment/utilities maintaining compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.
Under General Supervision to perform Mechanical Maintenance:
- Perform Preventive Maintenance and breakdown maintenance of tablet and capsule manufacturing and packaging equipment
- Experience for maintenance of Glatt and Niro fluid bed driers, tablet press, capsule filler, bottle packaging line, blister packaging equipment require
- Perform equipment installation and operational qualification protocol or non-routine tasks as necessary.
- Troubleshoot issues and problems for optimal running efficiency by solving simple to complex problems related to equipment or process.
- Maintain documents related to PM, breakdown maintenance and usage logbook
- Maintain spare parts inventory
- Develop and maintains records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
- Support area validation/calibration/certification efforts and the transfer of new processes to the manufacturing area
- Perform equipment/utility/plant maintenance as needed
- Follow all company policies related to job safety
- Support operations improvement/maintenance projects
- Perform improvements/maintenance as required to support all operations
Experience and Education:
- High School/Trade School/Vocational School Diploma, GED, or equivalent
- Black Seal Boiler License & HVAC Certification are preferred
- Boiler and Chiller experience if not certified
- Ability to read electrical drawings and control diagrams
- Ability to identify replacement parts from manuals and other resources
- Good Math and Computer Skills including MS Office and some experience with SAP
- Electrical and Control Troubleshooting skills with use of instrumentation (Multimeter)
- Welding, and plumbing knowledge including the ability to sweat copper tubing
- Knowledge of HVAC Systems and troubleshoot using the Building Management System
- Knowledge of Compressed Air/Pneumatic Systems and Troubleshooting
- Fabricate sheet metal guards and other simple replacement parts
- Operational understanding and troubleshooting process of manufacturing equipment such as Blenders, Sifters, Mills, Printing Machines, Dust Collectors, Tablet Dedusters, and Packaging Equipment
- Basic Operational understanding and troubleshooting process for medium level equipment such as Compression Machines, High Shear Mixers, Film Coaters, and Capsule Fillers
- Good Interpersonal skills
- Basic understanding of cGMP and OSHA Regulations
- The requirement for English language proficiency for this job role is Basic –A2 (comparable to Global CEFR Basic A2) level based on the Common European Framework of Reference for Languages (CEFR).
- Minimum four (4) years of Mechanical Maintenance experience in pharmaceutical solid oral product manufacturing.