Engineer 2 - Process Development
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.We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.