Job Description Summary
This position is part of Genentech’s’ Pharma Technical - individualized Neoantigen Specific Therapy (iNeST) team based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology.
As the Principal Engineer focusing on Validation Engineering, you will be supporting the design and start up of a GMP facility capable of manufacturing high throughput individualized therapies, you will help define the requirements for operational equipment and processes and will establish business processes that enable the organization to operate successfully. This role provides the opportunity to closely partner with the existing clinical facility, the iNeST User Team, Engineering Team and Process Technical Development as you work on start-up activities for the new cGMP facility, processes and equipment. You will be accountable for oversight of the validation lifecycle from Plan to Retire, for manufacturing processes and equipment. This includes oversight of Equipment Qualification and Process Validation as well as development and administration of the Periodic Review and Revalidation program. You will also provide technical leadership, guidance and support to the process engineers that will take guidance from you in performing validation activities. You will also represent the validation program during health authority inspections. The successful candidate will have a demonstrated passion for simplification and the application of risk based decision making to streamline validation activities.
- Develop and co-own the site validation strategy with site Quality. Drive for simplification and application of risk based validation.
- Partner with Quality, Global Engineering and the iNeST project team to drive completion of validation activities through handover.
- Accountable to lead the execution of Validation activities from handover through qualification and licensure of the iNEST facility.
- Apply quality by design principles during the validation lifecycle to ultimately reduce overall validation efforts and increase chances of success during validation
- Provide technical leadership and guidance for the process engineers executing validation activities.
- Author, review and approve GMP documentation and regulatory submissions.
- Provide leadership on projects, process improvements, and teams.
- Actively contribute to effective teamwork and quality decision-making.
- Oversee validation activities performed internal staff and contractors.
- Collaborate with PTQ on validation standards and implementation of quality policies.
- Provide input during process design activities to ensure robust validation.
- Ensure that staff works in the safest possible manner
- Ensure compliance with cGMPs.
- Minimum of BA/BS in engineering or science.
- Minimum of 12 years of biopharmaceutical industrial experience
- Expertise in the qualification and validation of pharmaceutical manufacturing equipment, lab equipment and pharmaceutical manufacturing processes.
- Demonstrated ability to lead, motivate and sustain creative output from a diverse technical staff.
- Expertise in the application of statistical methods to develop robust validation methodologies.
- Strong written and verbal communication, interpersonal, leadership, and team skills
- Successful demonstration of goal setting, delivering results, staff development, technical expertise, problem solving, training, recruiting, influencing, initiative and quality decision-making.
- Ability to travel up to 25% to support knowledge transfer and collaboration between teams in multiple locations. More than 25% travel may be required in the first year.
- Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing
- Builds trustful and effective relationships
- Able to think innovatively and translate ideas into actionable plans
- Takes responsibility, drives results, and achieves expected outcomes
- Work in office, production and laboratory environments
- Lift up to 25 lbs may be required
- Ability to sit, stand and move within work space for extended periods
- May be required to sit at a computer terminal for extended periods