We're seeking a Senior Process Engineer with hands-on experience in aseptic processing, vial filling, isolators, and cGMP manufacturing. The role focuses on troubleshooting, process optimization, and improving fill line performance.
Key Responsibilities
Optimize and troubleshoot fill lines, isolators, and aseptic processes.
Support Optima H610 MUST HAVE and automated vial filling equipment.
Support formulation, filling, and autoclave operations.
Develop and maintain SOPs, batch records, and process documentation.
Drive root-cause analysis and continuous process improvements.
Collaborate with manufacturing, quality, maintenance, and engineering teams.
Required Skills
Process Engineering experience in a pharmaceutical/GMP environment.
Aseptic processing and filling experience.
Optima H610 experience REQUIRED.
Vial filling equipment and isolator troubleshooting.
cGMP and manufacturing documentation knowledge.
Preferred: EMA filling line and reliability engineering experience.
Numbers & Facts
Location
NULL, IN
Salary
$50–$60
Skills
Asepsisunmatched
Autoclaveunmatched
Biotech and Pharmaceuticalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Manufacturingunmatched
Performance Managementunmatched
Process Engineeringunmatched
Process Improvementunmatched
Reliability Engineeringunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
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