Primary Responsibilities
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.
Responsibilities include:
• 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.
Key Technical Requirements
• 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.
