What are the responsibilities and job description for the Process Development Technician - II position at LanceSoft, Inc.?
Role Summary:
Drive execution of Commercial, Clinical, and/or Development production in accordance with Standard Operating Procedures (SOPs) and production schedules
Work within interdisciplinary, self-directed teams to support process improvements and troubleshoot manufacturing processes
Responsibilities:
Execute manufacturing operations on the production floor, including buffer/media preparation, glass washers, autoclaves, bioreactors, filtration systems, inoculum preparation, chromatography skids, and UF/DF systems
Perform and adhere to SOPs for unit operations such as CIP, SIP, and sanitization processes
Support equipment commissioning, qualification, and validation activities, including issue resolution
Troubleshoot and provide technical support for equipment, automation, and process-related issues
Ensure right-first-time execution through accurate documentation, timely data entry, and real-time monitoring of process and compliance trends
Support audit readiness activities, including walkthroughs, GMP observations, and continuous improvement actions
Maintain and review controlled documentation such as SOPs, batch records, formulation records, and related forms
Collaborate with SMEs on investigations (QTS) and CAPA implementation activities
Stay current with training programs and support ongoing learning related to manufacturing processes
Drive Lean Manufacturing, sustainability, and operational excellence initiatives for continuous improvement
Partner with cross-functional teams to support manufacturing campaigns and production goals
Escalate issues related to safety, equipment, product quality, or supply risks through appropriate channels
Generate and manage work requests for equipment-related issues
Utilize enterprise systems such as SAP, LIMS, AMPS, PDOCS, and QTS to support manufacturing operations
Maintain production sustainability through inventory management, reconciliation, and task prioritization to meet performance metrics