Aseptic Fill Finish Mechanic Sterile Injectables
Overview
Halo Pharmaceutical seeks an experienced Aseptic Fill Finish Mechanic to support sterile injectable manufacturing at their Whippany New Jersey facility. This onsite contract role requires hands-on experience with aseptic pharmaceutical manufacturing Fill Finish equipment and related maintenance tasks. The ideal candidate will operate and maintain equipment while ensuring cGMP compliance.
What You'll Do11
- 1Operate and maintain aseptic Fill Finish equipment for sterile injectable production
- 2Support automated filling systems for vials and syringes
- 3Perform preventive and corrective maintenance on filling equipment and sensors
- 4Maintain pharmaceutical isolator systems including H₂O₂/VHP decontamination
- 5Execute IQ/OQ/PQ and equipment qualification activities
- 6Troubleshoot mechanical electrical and automation issues
- 7Document maintenance activities using site CMMS
- 8Collaborate with engineering and quality teams on RCA and CAPA
- 9Ensure accurate documentation per cGMP and FDA regulations
- 10Work with manufacturers and OEMs for equipment changes
- 11Support change part management and setup activities
Requirements11
- 15+ years hands-on equipment maintenance in pharmaceutical environments
- 2Direct experience with sterile injectable aseptic manufacturing
- 3Knowledge of automated vial syringe and cartridge filling systems
- 4Experience with aseptic isolator or RABS technology
- 5Strong mechanical troubleshooting abilities
- 6Proficiency with cGMP and ISO 5 cleanroom operations
- 7Familiarity with CMMS systems and GMP documentation
- 8Ability to interpret technical manuals and schematics
- 9Education associate degree or technical certification preferred
- 10Experience with WFI/PW systems autoclaves and parts washers
- 11PLC/HMI troubleshooting skills
Salary Insight
$50k per year
Location
Required Skills
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