Biotech Manufacturing Engineer

Job Description

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

Attainment Indicators:

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.


CMC Biologics

Job Code

State or Province


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