This position is part of the Hillsboro Innovative Therapies (HIT) Analytical Development and Testing (ADT) team responsible for supporting the development of new modalities in the Pharma Technical Cell and Gene Therapy (PTC) organization, the position based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapeutics (CGT) for the treatment or cure of various diseases. In this role, you will perform Environmental Monitoring (EM) and critical utility monitoring activities in support of the clinical manufacturing of CGT.The Position is located in Hillsboro, Oregon, On-site (occasional need to work overtime and on weekends)The Opportunity:Responsibilities include sample collection, evaluation and data reporting, and coordination of required excursion response and restart activities. Additional responsibilities include managing consumables and maintaining equipment.Responsibilities:Execute non-viable air, viable air, surface, and critical utility sample collection in a cleanroom and/or unclassified environment with documentation according to cGMPPartner closely with Quality Assurance to ensure the Environment and Utility Monitoring programs are in compliance with internal standards and regulationsUse SOPs in full compliance with cGMP regulations and evolving expectationsDevelop new business processes to constantly improve ourselvesIdentify gaps, technical problems, deviations and discrepanciesNotify Management of potential quality or regulatory issues that may affect product quality or regulatory complianceReceive and provide trainingSupport the maintenance and compliance of operational areasWork to meet schedules, timelines, deadlinesPerform any other tasks as requested by Management to support site and analytical activities.Who you are:Qualifications/Requirements:B.S./B.A. Degree in a relevant scientific discipline or previous experience performing Environmental Monitoring (EM) and knowledge of cGMP regulationsDemonstrated ability to work independently to accomplish tasksStrong verbal and written communication skills, ability to organize and present information both formally and informallyAbility to follow Quality standardsFlexibility in problem-solving and work hours to meet business objectivesWork in a clean room environment. Prolonged periods of standing/sitting. Frequent lifting (up to 25 lbs), bending, reaching, twisting.Relocation benefits are not available for this posting.Genentech is an equal opportunity employer, and we embrace the increasingly diverse world. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
