At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.  We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion.  We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire.  Our Pharma vision is to have a greater overall patient benefit and impact.  This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life.  We hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world! 

The Validation Engineer / Senior Validation Engineer position is responsible for defining validation strategy and coordinating Validation activities required to complete assigned validation projects in support of the operation of the Vacaville Commercial Manufacturing Facility.  An ideal candidate would have previous experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire.

Responsibilities of the Position:

• Responsible for oversight and performance of Commissioning and Qualification of equipment, utility systems, automation systems, processes and facilities.
• Prepares/Updates Validation Master Plans, Project Plans, and Protocols; Commissioning Plans, performs testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.
• Peer Reviews/Approves Validation Protocols, Commissioning Plans, analyzes and approves test results, and approves summary reports generated by junior and contract personnel.
• Leads efforts by representing the department on project teams and coordinates activities of MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects.
• Prepare specific validation summary sections of regulatory submissions and present equipment validation packages to regulatory authorities during routine and pre-approval inspections.
• Leads/participates in resolutions to regulatory observations through the CAPA system.
• Leads the efforts to evaluate gaps, develop remediation plans and driving remediation through the CAPA system for the role out of new/revised Roche PQS requirements.
• Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.
• Provide leadership to group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
• Promotes good interdepartmental relations.
• Maintain Training to ensure job responsibilities can be performed on a daily basis.
• Vigilant to safety and maintains a safe environment for all during performance of job responsibilities (i.e. Validation Field Execution).

Who You Are

• Bachelors degree (Engineering, Life Science, Biology, Biochemistry) – recommended
• Minimum of 4 years (Validation Engineer E2) / 8 years (Sr. Validation Engineer E3) of direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing equipment, facilities, utility and automation systems.
• Proficient / Thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
• Strong technical writing, verbal communication, interpersonal and problem solving skills.
• Ability to work independently, organize and manage individual as well as lead larger scale projects.

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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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.