Execution of batch operations as described in Standard Operating Procedures (SOPs) and batch execution records including, but not limited to: Cleaning, Expansion, Cell Culture, Harvest, Filtration, Purification, Formulation and Final Fill activities
Review / approval of completed batch execution records and related cGMP documentation
Assist in scheduling of Technical Operations staff to support operations activities
Perform Root Cause Analysis (RCA) in support of investigation and documentation required in a cGMP environment
Assist in project management for process and utility improvement projects
Providing analytical, data management, and equipment support
Troubleshooting and analysis of equipment malfunctions to assist in repair and return to service activities
Specification of equipment and process parameters
Facilitation and/or execution of equipment on-boarding/commissioning activities
Technical direction and training of equipment operations to colleagues
Promoting a safe working environment
Standardization of processes
Right First Time batch execution
Development / Training of colleagues
Restore Lost Function
Safe working environment
Perform his/her tasks diligently and in compliance with requirements in CMC’s Quality System
Other duties as assigned
BS in Engineering or related field / equivalent experience.
8+ years engineering experience in Biotechnology Manufacturing operations,
Maintenance, Design, Process Improvement, Root Cause Analysis (RCA)
Knowledgeable in the following systems: BioRx operations, Chromotography System operations, Biopharmaceutical Filtration operations, Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM); Pharmaceutical Utilities
Proven expertise in planning/organization/execution of operation and maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams.
Ability to work hours necessary to support production and /or maintenance activities.
Ability to lift up to 40 lbs. with assistance
Ability to work in confined spaces and near operating equipment.
Ability to work in loud noise environments.
State or Province