Coordinate Quality and Validation actions. Provide a high level of skill in at least three mechanical disciplines.
Provide solutions to complex facility operation and maintenance situations.
Coordinate and lead entry level facility repair projects.
Provide overall support for GMP facilities operation.
Responsible for the operation and preventive maintenance (per SOP requirements) of all purified water systems (RO, DI, WFI) and associated equipment, pure steam generators, plant steam boilers, air compressors, vacuum systems, chillers, HVAC units, and associated equipment, hot HVAC water boilers, and other miscellaneous equipment that supports the manufacturing facilities.
Ensure all utility systems and utility sub-systems at BioMarin are operated and maintained in the following manner.
Execute PM and general work orders, i.e., hands on position (approximately 80%). Ensure all assigned PM’s and WO’s
are completed in a timely manner.
Identify mechanical malfunctions and implement complex corrective actions.
Assist in the completion of Quality Deviations and other Quality Control actions.
Assist in completion of Quality Assurance Change Requests.
Ensure daily planned inspections of facilities equipment and services are performed. Take actions as needed.
Complete Shift Transition Log to assure adequate review of alarms or other operating conditions or instructions.
Coordinate department activities with manufacturing supervisors and establish necessary support for manufacturing process equipment maintenance.
Provide guidance to other Mechanics on various projects including plumbing, electrical, and mechanical.
Write Standard Operating Procedures.
Perform troubleshooting, evaluation, and repair of complex equipment and process control systems.
Coordinate with outside contractors as necessary. Assure contractor compliance with EH&S requirements (waste disposal, hot work permits, confined space, LOTO, etc. and Contractor Technical Certifications program).
Maintain detailed and accurate records as necessary in order to maintain GMP and department procedure compliance.
Provide validation execution assistance.
Provide guidance and assistance in the start-up of new mechanical systems.
Train other mechanics for mechanical repair and maintenance.
Provide Job Safety Analysis (JSA) in maintenance area.
Participate in teams and upkeep of data elements for the Computerized Maintenance Management System (CMMS).
Participate on the BioMarin Emergency Response Team (BERT).
Other projects/tasks as assigned by supervisor or management.
Ensure all FAC/MFG are up to date on what is going on in with the facilities equipment sending utilities update on a daily basis.
BS with 1-2 years’ experience. Highschool diploma with 5+ years’ experience.