Location: San Francisco
The Senior Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
The candidate has technical expertise in the development and commercialization of drug-device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Genentech’s device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges.
The Senior Engineer will be assigned responsibilities to perform tasks and will assist other Engineers in developing solutions to problems by addressing issues of moderate scope and complexity.
The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members.
The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
Component selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
Regularly interface with staff and leaders in Contract Manufacturing, Project Core Teams, Development, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.
Regularly interacts with external development partners and component suppliers.
Drive problem solving using state of the art tools such as DMAIC, DFFS, DOE, Modelization, Monte Carlo Simulation and Probabilistic Design.
Quality System Compliance:
Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Use local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
Ensure compliance of training to PQS and job-related requirements.
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.