· Job facts
· Provide technical expertise to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities
· Provide technical expertise for 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, trouble shooting 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 implementation.
· Participate in 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 hurts.
Education and Experience
· BS/MS/PhD in a biological or engineering (preferred) discipline – Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related field 5+ years experience in upstream biologics process development, technology transfer, pilot plant, or manufacturing support.
· 5+ years applicable equipment and process system experience.
Knowledge, Skills and Abilities
· Solid technical understanding of upstream cell culture processes
· 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 GMP 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.
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.