This position is in Manufacturing Science and Technology (Fill MSAT), supporting Commercial Drug Product Operations and Validation in Hillsboro. In this position, you will need to work effectively as part of a team responsible for ensuring successful and efficient Drug Product operations.
Utilize Lean Production System elements and methods to continuously improve Drug Product Operations and Process Engineering processes and procedures.
Prepare development, characterization, validation & change control documentation, including protocols, summary reports, etc., for development and validation activities.
Support Investigations and atypical events, as well as resulting corrective or preventive action implementation
Owns activities of moderate scope & complexity (ex. Owns change records, responsible for CAPA actions, executes small scale/validation studies, performs troubleshooting, & monitors operations).
Provide troubleshooting and issue resolution support for the Drug Product operations to decrease time of recovery from process and or equipment malfunctions
Participate in the identification, evaluation, and implementation of new process technologies in alignment with business objectives or regulatory requirements
Support the change management system for validated equipment, utilities and facilities.
Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
On a regular basis analyze processes, make suggestions for improvement to management, & provide input to improving systems/processes.
Frequent use & application of basic Engineering/Scientific/GMP theories, principles & techniques.
Demonstrated capability of applying a broad scope of regulatory policies, guidelines & requirements applicable to assigned area and suggesting improvements.
Ability to support internal & external Health Authority inspections.
Represents group on cross functional teams or projects of limited scope
Qualifications / Requirements:
BS/MS in engineering, or related field/experience, with a minimum of 8 - 10 years experience in Process Development, Engineering, Manufacturing, or Technical Services is required.
Working knowledge of formulation and filling processes and equipment in a regulated environment is preferred.
Knowledge of cGMPs or equivalent regulations.
Working knowledge of formulation, filling, packaging and equipment/process characterization and qualification in a regulated environment is required.
Demonstrated understanding of project management and validation skills.
Ability to work with internal teams, partners, suppliers and customers.
Professional level written and oral communication skills.
Key to this position is the demonstrated ability to provide technical input and teamwork in a cGMP environment across functional and organizational boundaries
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.