Process Engineer

Hello,

We are urgently seeking a Process Engineer .

Responsibilities:

• Support commercial drug product manufacturing operations with technical evaluation of CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection) and reserve samples (creation, storage, and testing).
• Support of regulatory filings and inspections.
• Troubleshoot issues with drug product processing technologies and equipment.
• Projects involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management
• Conduct risk assessment for drug product operations non conformances, change controls, and implement appropriate CAPAs.
• Lead process modelling, data trending and advanced statistical & process analysis – present data/metrics to teams.

Qualifications and Education:

• BS/MS in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering,Industrial Engineering, Biomedical Engineering, or Science
• Bachelor's Degree 1 -5 years of Process Engineering or Operations experience .
• Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues.