Manufacturing Sciences and Technology (MSAT) Process Engineer

Orca Bio•Princeton, NJ

23h•Onsite

About The Position

The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.

Requirements

B.S. in Engineering or similar fields
3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
Prior experience in regulated, GMP manufacturing operations
Strong communication and problem solving skills, with a desire to improve upon established processes
Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.

Nice To Haves

Experience in biotechnology and cell therapy manufacturing preferred

Responsibilities

Performs ongoing monitoring of existing products and processes
Generate metrics and reports for process monitoring and continuous process verification
Support process improvements and changes including electronic batch record creation and modifications
Investigates process events and implements corrective and preventive actions
Provides troubleshooting support for manufacturing events, equipment performance and material issues
Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities