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Senior Engineer, Process Engineering (HIT)

Company: F. Hoffmann-La Roche AG
Location: Hillsboro
Posted on: September 17, 2020

Job Description:

Senior Engineer, Process Engineering (HIT). Please note there are multiple positions available. Main Purpose of the Position :. This position is part of the Manufacturing Science and Technology (MSAT) function at Genentech’s Hillsboro Individualized Therapies Operation (HIT). HIT is a new manufacturing facility focused on delivering novel therapies that are uniquely manufactured for each patient.. In this role, you will design, install, test, and validate state-of-the-art manufacturing equipment intended to produce medicine on a per-patient basis. Additionally, you will write product impact assessments, sampling, plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes and documentation pertaining to process development, qualification, and validation to meet regulatory requirements.. Responsibilities :. Provide technical support and training to Operations and Maintenance. Build reliability into Operations equipment and processes. Establish equipment failure and risk analysis processes to increase reliability. Provide frontline troubleshooting and issue resolution support for operations.. Support product & component introductions. Identify and implement batch & yield improvements. Identify and implement process & safety improvements. Support Investigations and atypical events, as well as resulting corrective or preventive action implementation. Root cause analysis facilitation/participation. Development and execution of integrated, startup, and qualification (IQ/OQ/PQ) activities. Training program development; Participate in FAT efforts at vendor sites. Identify, evaluate, and implement new process technologies in alignment with business objectives or regulatory requirements. Qualifications / Requirements :. B.S. degree engineering or related field. Possess a minimum of 8 years of experience in the Pharmaceutical Field. Experience with cell therapy manufacturing is preferred. Knowledge of filling and related equipment and processes is preferred. Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries. Excellent communication skills are a must. Ability to assess and develop timely, effective solutions for manufacturing equipment and processes is key. Six Sigma Green or Black Belts is a plus. Roche is an equal opportunity employer.. Manufacturing, Manufacturing > Production Engineering. Roche Diagnostic is the world leader in in-vitro diagnostics. Working at Roche means working at the forefront of innovation. Over the yea.... Thousands of employers search for candidates on Indeed

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Keywords: F. Hoffmann-La Roche AG, Hillsboro , Senior Engineer, Process Engineering (HIT), Other , Hillsboro, Oregon

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