Senior Project Engineer
500 Forbes Boulevard South San Francisco, CA 94080
Bayside Solutions is seeking a Senior Project Engineer I to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Senior Project Engineer:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Senior Process / Manufacturing Engineer will be responsible for providing medical device production innovation in support of project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
- Have in depth experience in low to high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within our company’ s device development programs, including internal engineering partners and external design/development partners and component suppliers.
- The Senior Process / Manufacturing Engineer will be assigned responsibilities that will include OEM supplier interface, CMO/supplier interface to ensure translation of product requirements to automation and assembly processes, process and method development and validation oversite, and design transfer.
- The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel.
- The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities to meet project timelines.
- Up to 25% domestic travel may be required
Quality Systems Compliance:
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) 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.
- 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:
Process / Manufacturing Engineering:
- Understanding of GAMP concepts to facilitate a systematic translation of product requirements to new manufacturing equipment and manufacturing process outputs
- Understanding of injection molding tooling design, processes, and process capabilities to provide robust and repeatable components for assembly
- Proficiency with common medical device assembly processes that including insert molding, overmolding, micro-volume adhesive application, curing, and automated inspection in semi-automated and automated device assembly
- Oversite of process and test method development and validation activities at external suppliers
- Support design transfer activities
- Familiarity with clean room manufacturing processes that will facilitate manufacturing in a low particulate space
- Collaboration with internal and external suppliers at a detailed technical level with design engineers, equipment and production engineers.
- Provide engineering technical leadership to internal cross functional team and external development partners and component suppliers.
Summary of Qualifications:
- B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
- At least 8-10 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor’ s degree.
- In depth experience in low to high volume manufacturing processes and methologies, with an emphasis in injection molding, mechanical assembly, and packaging operations is expected.
- Working knowledge of design transfer, equipment development, medical device process validation, and test method validation is highly desired.
- Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.
- Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.
- Strong skills in relevant modeling and design tools, design controls and/or statistical analysis.
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD (Solidworks, AutoCad), Design for Manufacturability, Molding.
- Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
- Design Controls for regulatory compliance & filing (ISO 13485, etc.): GDP/GLP/GMP, Design History Files, protocols /reports, etc.
- Equipment development and qualification principles: URS, FAT, SAT, IQ, OQ, Trace Matrix
- Six Sigma (Green/Black Belt): DMAIC and DFSS
- Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., validation, quality, regulatory, and program management) and collaborative environment is very desirable.
- Excellent oral and written communication skills are required.
- Able to work with external design/development and production partners is also highly desirable.
- Highly organized and detail oriented.
- Excellent leadership skills.
- Demonstrated success in project planning, resource management, and liaisoning with engineering and manufacturing resources, potentially in other countries.