Job ID :
US - California - Pleasanton
- Develop, implement, and qualify robust, high quality, and cost effective processes for manufacturing new and/or existing world class products in an ISO 13485 environment.
- Provide technical leadership on cross functional teams for high throughput oligonucleotide operations, business development and planning, and R&D activities.
- Lead equipment/process/facility specification & validation activities, process optimization, technology transfer, and new product scale-up.
- Lead technology transfers from R&D to Manufacturing and/or from manufacturing
site to manufacturing site.
- This position will have responsibilities for the evaluating existing processes and facility layouts and assist in generating the future strategy to maximize operating efficiency, sustainability, and growth.
- Perform project management functions.
- Successfully troubleshoot equipment and process problems in Manufacturing.
- Perform design and process risk assessments, such as FMEA.
- Design and conduct engineering experiments, critically analyze complex data using knowledge of advanced engineering statistics, and communicate results in a team environment.
- Identifies and solves engineering problems
- Exercise knowledge of Lean/Six Sigma principles in manufacturing.
- Conduct process analysis and root cause analysis for manufacturing processes. Utilizes PPI / DMAIC tools to promote a disciplined investigation approach.
- Investigates, creates and develops new methods and protocols for project advancement.
- Develop manufacturing documentation such as engineering changes, BOMs, fab drawings, flow diagrams, SOPs, Procedures, and assembly drawings. Develop and maintain records on equipment manufacturers’ technical notices, upgrades and safety issues.
- Maintains accurate records & training file in accordance with relevant Thermo Fisher Scientific required standards to support patent application and defense as well as other international standards (e.g. ISO compliance, GLP/GMP requirements, etc.).
- Develop and deliver operator and maintenance training and certification.
- Monitor and collect data regarding systems performance and report to management; utilize statistical process controls. Identify existing and potential problems and develop resolutions. Proactively identify problems before they occur, recommend solutions and implement changes to design and/or process as necessary.
- Initiates, directs and executes engineering research and/or development strategies through engineering staff or individual studies.
- Proactively identify future projects, specifications, and benefits.
- Requires a bachelor’s degree or higher in Chemical Engineering or related discipline. Requires a minimum of eight years of relevant experience in successfully performing process engineering activities.
- Must have manufacturing experience, with strong understanding of ISO 13485 and cGMP quality requirements.
- Excellent project management and interpersonal skills are required, providing the ability to inspire, motivate, and collaborate with others.
- Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
- Experience in computer-aided design and analysis tools including SolidWorks, JMP, MiniTab, Word and Excel/ VBA
- Familiarity with design for six-sigma (DFSS) and critical parameter management (CPM) processes is desirable.
- Knowledge of life-science research market a plus; instruments, protocols, molecular biology, and biochemistry.
- Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
- Demonstrated expertise in engineering techniques/fundamentals and analytical problem solving skills.
- Proven ability to lead and provide work direction required.
- Proficient in product and process change controls and risk management
- Broad experience in fabrication techniques such as molding, castings, machining, forming, bending, etc. is a plus