Downstream Process Engineer

The primary objective of this position is to ensure manufacturing equipment is operationally ready to support production. Approximately 50% of the role involves hands-on troubleshooting and resolving equipment or process-related issues on the manufacturing floor.

 

•     Verifying equipment readiness, including preventive maintenance, operational checks, and manufacturing recipe functionality.

•     Troubleshooting downstream processing equipment and resolving technical issues impacting manufacturing.

•     Investigating equipment-related deviations, identifying root causes, and supporting corrective actions.

•     Authoring and revising Operational Design Documents (ODDs), Operational Qualification (OQ) documentation, and equipment-related SOPs.

•     Reviewing equipment records, technical documentation, and historical investigations to identify information and resolve issues.

•     Collaborating with Manufacturing, Facilities, Maintenance, Quality, Validation, and Document Control teams.

•     Providing occasional support to upstream manufacturing operations as needed.

 

•     5+ years of downstream process engineering experience in biopharmaceutical manufacturing.

•     Strong hands-on equipment troubleshooting and manufacturing support experience.

•     Experience with TrackWise, particularly equipment-related deviations and investigations.

•     Strong GMP documentation and technical writing skills.

•     Familiarity with KNEAT.

•     DeltaV, UNICORN, and Veeva experience are additional advantages.