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Sr. Engineer (Downstream Manufacturing Sciences & Technology) New


Hoffmann-La Roche Ltd


Oceanside, United States

United States





Not specified

Permanent | Full Time

We are seeking an enthusiastic and highly motivated engineer dedicated to providing scientific and technical support to downstream bioprocess manufacturing operations. This role is responsible for receiving new processes from Process Development or other manufacturing sites, process monitoring and analysis, process performance troubleshooting, as well as establishment and maintenance of the process validated state and ongoing process improvement.In this position, you will support the design, installation, commissioning and validation of cGMP processes and equipment originating from tech transfers and/or capital projects. Your focus will also be placed on providing support for existing processes and equipment through continuous improvement activities by leading and working with multi-functional teams.This is an ideal position for an inpidual interested in leadership opportunities and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.Job Responsibilities* Provide technical expertise to lead process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities.* Provide technical expertise to lead the commissioning and validation of processes, process equipment and associated utilities through teams composed of cross functional SMEs.* Provide technical leadership to monitor process health through process monitoring, troubleshooting of processes and process equipment.* Liaise with site functions - Manufacturing, Process Development, Planning, QA, QC, Operations, and Regulatory Affairs to support the process transfer and project.* Lead gap analyses and risk assessments to support the tech transfers.* Author tech transfer related projects plans, assessments, and process validation protocols.* Review and provide recommendations on design drawings, which may include PFDs that incorporate mass balances and P&IDs, which include all line sizing, instrumentation and control philosophies.* Interact with vendors concerning contracts of critical financial value and select vendors based on the most appropriate combination of price, quality and delivery. This often involves negotiations of a complex and/or controversial nature. Review and approve vendor information packages, including drawings and specifications. Make recommendations to senior staff.* Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning, problem solving, etc, in alignment with corporate objectives.* Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.* Provide key input into the validation of process equipment and associated utilities. Direct manufacturing and operations staff in the execution of validation protocols.* Provide technical support to manufacturing.* Provide technical assessments for investigations, validation and change control.* Manage corrective actions as a result of investigations.* Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.Job RequirementsEducation and Experience* BS/MS/PhD in a biological or engineering (preferred) discipline - Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related field.* 8+ years experience in downstream biologics process development, technology transfer, pilot plant, or manufacturing support.* 8+ years applicable equipment and process system experience.Knowledge, Skills and Abilities* Solid technical understanding of downstream processes (harvest, chromatography, viral filtration, and/or UF/DF).* Thorough knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.* Experience in the design, installation and operations of cGMP processes and equipment.* Process troubleshooting and experimental design.* Prior experience in biological/viral commercial manufacturing facility.* Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.* Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.* Excellent organization and time utilization skills.* Excellent communication skills, both written and verbal.* Use creativity and innovation to address urgent and/or complex problems and propose solutions.For questions regarding this search, please contact Carla Baja, Principal Talent Partner, at

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