Senior GMP Equipment Mechanic

Abzena

Bristol Township (Bucks County)

On-site

USD 65,000 - 90,000

Full time

14 days+
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Job summary

Abzena is seeking a GMP Mechanic to join the Facilities Maintenance team. You will perform preventive and corrective maintenance on GMP manufacturing and lab equipment, troubleshoot failures, and support installation and validation activities to ensure regulatory compliance.

This hands-on role requires reading drawings and P&IDs, using CMMS, and collaborating with Manufacturing, Engineering, Validation, Quality, and Laboratory Operations to improve reliability and safety in a regulated

Qualifications

  • High School Diploma or GED required.
  • Technical trade school certification or equivalent mechanical apprenticeship preferred.
  • Minimum of 3 years of industrial maintenance experience in regulated environments.
  • Experience troubleshooting mechanical process equipment in GMP manufacturing.
  • Familiarity with pumps, valves, piping, gearboxes, conveyors, motors, bearings, seals, and rotating equipment.
  • Experience with sanitary piping systems and stainless steel process systems preferred.
  • HVAC familiarity and pharmaceutical utilities knowledge (compressed gases, purified water, clean steam).
  • Experience using CMMS systems (Blue Mountain, Maximo, eMaint, or equivalent).
  • Ability to read mechanical drawings, equipment manuals, and P&IDs.

Responsibilities

  • Perform planned preventive maintenance on GMP manufacturing equipment, laboratory equipment, and facility infrastructure.
  • Perform corrective maintenance and emergency repairs to minimize downtime.
  • Troubleshoot mechanical, pneumatic, hydraulic, and process equipment failures.
  • Maintain and repair manufacturing equipment including bioreactors, chromatography systems, and process vessels.
  • Maintain facility equipment including HVAC systems, purified water and other utilities.
  • Support maintenance activities in classified cleanrooms with proper gowning and contamination control.
  • Document work orders in CMMS with GDP and cGMP compliance.
  • Support equipment installation, commissioning, and validation activities.
  • Assist Engineering with modifications and continuous improvement initiatives.
  • Participate in root cause investigations, deviations, CAPAs, and change controls.

Skills

Troubleshooting
CMMS
Drawings
cGMP
HVAC
Teamwork

Education

High School Diploma or GED
Technical trade school certification

Tools

CMMS software

Job description

Abzena is seeking a GMP Mechanic to join the Facilities Maintenance team. You will perform preventive and corrective maintenance on GMP manufacturing and lab equipment, troubleshoot failures, and support installation and validation activities to ensure regulatory compliance.

This hands-on role requires reading drawings and P&IDs, using CMMS, and collaborating with Manufacturing, Engineering, Validation, Quality, and Laboratory Operations to improve reliability and safety in a regulated

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