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+
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Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.