All listings

Senior Maintenance Technician

Fremont, CA · Full time

Job Description

Troubleshoot and repair mechanical and electronic technologies used throughout a cGMP biopharmaceutical facility

Performs both corrective and scheduled preventive maintenance on production, facility, and utility systems in a GMP environment (HVAC, PW, Autoclave, CDA, bioreactors, purification skids)

Assist in setup and operation of CMMS system (as a GMP validated system)

Assist in coordination of Calibration vendor daily scheduling

Assist in Maintaining Calibration process as compliant quality system

Creation of documented GMP maintenance procedures

Non-GMP maintenance (Lights, office temp, doors, HVAC, hard vendor contracts)

Management of vendors to perform necessary maintenances on specific equipment that can not be maintained by internal resources. Oversee and accept paperwork created by vendors.

Maintain current state of training with cGMP SOPs

Provide after-hours on-call support (only when) necessary

Execute, document, and close work orders in a compliant and complete manner

Order parts and components for jobs as needed

Manage inventory of spare parts in maintenance shop

Upkeep and stocking of maintenance shop as consistently ready to perform cGMP maintenance on pharmaceutical manufacturing equipment

Manage maintenance and calibration of facility and pharmaceutical process equipment that use disposable technologies

Qualifications/Skills required

Experience using/setting up CMMS systems in FDA-regulated industries

At least 3 years experience performing maintenance in a cGMP environment

Experience managing/interacting with calibration vendors

Excellent verbal and written communication skills with understanding of needs to document all maintenance activities

Experience interacting with regulatory agencies to defend maintenance program a plus+

Ready to Apply?

Send your cover letter and resume to the email address below.

Email us