Sterile Mechanic


Job ID 18-00005

Industry Pharma

Job Type Permanent

Location Buena, NJ

Description

 2nd Shift (2:00PM – 10:00PM) They would likely start on 1st shift and then transition to the 2nd
 
The Sterile Mechanic will perform sterile filling and formulation equipment changeovers, operation, sampling, maintenance, and repairs in accordance with approved procedures.  Responsibilities include proficiency at analyzing and troubleshooting the root cause of equipment and process problems and implementing effective solutions including preventive and/or corrective maintenance repairs.
 
Essential Responsibilities
•Demonstrate technical knowledge and experience in mechanical and electrical support systems to include aseptic filling and formulations equipment.
•Demonstrate mechanical ability to troubleshoot equipment related to the sterile manufacturing area – Tanks, pumps, washer, tunnel, filler, sterilizer and other ancillary manufacturing equipment in GMP environment.
•Assumes overall responsibilities related to sterile area maintenance, repairs and upgrades.
•Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
•Perform preventive maintenance tasks on all sterile filling, formulation, and manufacturing equipment per the frequency written in the SOP.
•Operate the filling line and formulation equipment with sterile operators as needed
•Perform microbial sampling per applicable SOPs.
•Learn and demonstrate behaviors related to safety, quality, and production.
•Follow and adheres to all cGMPs, compliance/regulatory mandates, SOP's and quality requirements.
•Cleanroom experience in ISO 5, 7, or 8 is required.
•Interface with external vendors & service providers.
•Other duties as assigned.



Qualifications

Qualifications
•High School Diploma or GED.  Technical school preferred.
•Minimum 5 years of experience in a Sterile filling and manufacturing environment, which include maintenance related activities in Pharmaceutical or Medical device GMP environment.
•Demonstrated ability to work with minimal supervision
•Ability to read and understand written procedures and instructions.
•Demonstrated ability to work in a team environment.
•Excellent communication skills.