4 head of project engineering jobs found

Biogen About This Role As a member of Manufacturing Sciences within the Parenteral Filling area, the Sr. Engineer II will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Pharma Site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging. What You'll Do Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site. Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed. Provide technical and operational guidance to Manufacturing during GMP campaigns Lead technical investigations towards process impact assessments and ensure timely completion and communication Author Manufacturing and Process Performance Qualification validation protocols and...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...

Biogen This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required About This Role We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies. What You'll Do Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA...

Biogen This position follows a traditional 2-2-3 format from 6p-6a (Night Shift) About This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. In coordination with Supervisor, schedules tasks for a given shift and plan...