Manufacturing Process Engineer

PCI Pharma Services

Manufacturing Process Engineer at PCI Pharma Services in Bedford, NH supports aseptic filling and related operations through process optimization, equipment troubleshooting, and validation activities. The role focuses on minimizing manufacturing variability, leading process improvements, and ensuring compliance with GMP and regulatory standards.

Responsibilities

Support process optimization and troubleshooting for new and existing aseptic filling products
Gather and analyze data to minimize waste, variability, and improve manufacturing yield
Write standard operational procedures, test protocols, and GMP-compliant documentation
Lead commissioning and qualification activities for manufacturing equipment including FAT/SAT
Investigate manufacturing issues and lead corrective action initiatives to ensure compliance

Requirements

Strong understanding of aseptic filling, capping, and lyophilization manufacturing processes
Experience with process validation, equipment qualification, and commissioning activities
Proficiency in Lean Six Sigma and process improvement methodologies
Knowledge of GMP regulations, cGCP policies, and regulatory compliance requirements
Ability to write and execute technical documents including SOPs, protocols, and batch records
Experience troubleshooting manufacturing equipment and leading CAPA initiatives

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Vacancy posted 3 days ago

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