Senior Maintenance Mechanic

Summary 

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Job Description:

• Safely Troubleshoot and repair mechanical and electronic process equipment and technologies used throughout a cGMP biopharmaceutical facility
• Perform both unscheduled corrective and scheduled preventive maintenance on production, facility, and utility systems in a GMP environment (HVAC, PW, Autoclave, CDA, bioreactors, purification skids)
• Support setup and operation of CMMS system (as a GMP validated system)
• Coordination of Calibration vendor daily scheduling
• Assist in Maintaining Calibration process as a compliant quality system
• Creation of documented GMP maintenance procedures
• Non-GMP maintenance (Lights, office temperature, doors, HVAC, hard vendor contracts)
• Management of vendors to perform necessary maintenances on specific equipment that cannot 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
• Support Supply Chain and Shipping & Receiving departments in movement of goods

Qualifications/Skills required:

• Significant experience using and/or setting up CMMS systems in FDA-regulated industries
• At least 5 years of experience performing maintenance and calibrations in a cGMP environment
• Experience managing and/or interfacing with calibration vendors
• Excellent verbal and written communication skills applied to documentation of all maintenance
• Experience interacting with regulatory agencies to defend the maintenance program is a plus