Position Summary:

We are looking for driven, talented Process Engineer to join Reagent Development Services team in the Manufacturing Technology Transfer (MTT) group. The MTT group works as an integral part of our Consumables Development and Manufacturing process and is tasked with developing and deploying consumables manufacturing processes of both new and existing products within our production environments.

Responsibilities:

• Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products used in Illumina's sequencing and Array technology
• Work cross functionally with Product development, Supply chain, Manufacturing and Quality to develop processes for new products and improve processes of existing products
• Perform DOEs for particle characterization and particle formulation.
• Perform plate based assays such as binding assays, fluorescent, FRET, DLS, etc
• Perform high complexity molecular testing using a variety of molecular biological methods including PCR, real-time PCR and DNA sequencing including sequencing analysis
• Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals
• Define technical requirements for manufacturing processes and new production equipment
• Work on teams to develop and transfer new processes/products to production and enhance their robustness
• Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
• Represent Operations needs on development teams for effective transfer of products into manufacturing
• Troubleshoot production line issues related to yield, quality and throughput
• Analyze process test results, issue reports and make technical recommendations
• Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders

Requirements:

• Work experience in the medical device, biotech, pharmaceutical or semiconductor industries is desirable
• Strong background and working knowledge of molecular biology/biochemistry principles and techniques.
• Experience with surface chemistry and protein/oligo characterization techniques preferred
• Hands-on experience with organic synthesis and materials synthesis techniques in a laboratory setting
• Experience with nanoparticles and oligos preferred
• Effective communication skills both verbal and written, analytical and organizational skills to manage different priorities
• High level problem solving, and reasoning skills required
• Experience with statistics, Statistical Process Control and DOE techniques is a plus
• Experience with high volume production in a high-tech, high-volume consumables industry is a plus
• Experience with lean Six Sigma is a plus
• Experience with product development processes and project management is a plus
• Good interdepartmental communication skills and documentation skills are required
• Demonstrated ability to accomplish goals while working across departments is required
• Ability to work independently and collaborate
• Adhere strictly to lab cleanliness protocols, ensuring routine cleanup of bench spaces, proper chemical disposal, and glass washing after daily operations.

Education and Experience:

BS/MS/PhD in Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering Materials Science or related field with 2-5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation

The estimated base salary range for the Engineer 2 - Process Development role based in the United States of America is: $82,500 - $123,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.