Sr Engineer - Process Development

Illumina; San Diego (CA); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Genomics sequencing access

Family planning benefits

Health/dental/vision insurance

Retirement benefits

Paid time off

Job summary

Illumina is seeking driven Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. You will develop and deploy oligonucleotide manufacturing processes and partner with development, Quality, Production, and Supply Chain teams in a GMP setting.

Responsibilities include executing feasibility builds, creating production equipment requirements, authoring procedures, and training operators to manufacture products.

Qualifications

• Minimum 5 years oligonucleotide experience with a Bachelor’s degree; or 3+ years with a Master’s; or PhD without chemistry/biochemistry/chemical engineering experience.
• Experience with cGMP and 21 CFR Part 11 in an FDA-regulated environment.
• Strong cross-functional collaboration and communication skills.
• Experience with DOE and Statistical Process Control.

Responsibilities

• Execute feasibility and development oligonucleotide builds to support project timelines.
• Define technical requirements for new production equipment and processes.
• Author procedures and train operators for GMP manufacturing.
• Troubleshoot yield, quality and throughput issues in production.
• Conduct DOE-based experiments to optimize processes and scale for production.
• Analyze results, write reports and propose process improvements.
• Collaborate with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities.
• Ensure knowledge transfer to manufacturing and sustaining teams.

Skills

Oligonucleotide synthesis

Oligonucleotide QC

HPLC

DOE

cGMP

21 CFR 11

Statistical Process Control

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry/Biochemistry/Chemical Engineering

Tools

Synthesis equipment

HPLC systems

MS instruments

UV spectrometers

Job description

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary

We are looking for driven, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Development team and is tasked with developing and deploying oligonucleotide manufacturing processes. The individual will partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes.

Responsibilities

• Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
• Ideate and create manufacturing processes and define technical requirements for new production equipment
• Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
• Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
• Construct and execute controlled experiments including DOE's to optimize processes and scale; address yield/quality issues and drive implementation of solutions into a production environment to meet project goals
• Analyze process test results, author reports and inform technical recommendations to improve product and process quality
• Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities teams by representing Oligo MTT on NPI core teams
• Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

Requirements

• Expertise with all oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV Specs, etc)
• Experience with liquid handlers and ERP systems is a plus
• Demonstrated ability to accomplish goals while working across departments
• Effective communication (both verbal and written) and organizational skills to manage competing project priorities
• Expertise with Statistics, Statistical Process Control and DOE techniques
• Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
• Experience with high volume production in a high tech consumables industry is a plus
• Experience with product development processes and project management is a plus

Education / Experience

• Typically requires a minimum of 5 years of related oligonucleotide experience with a Bachelor’s degree; or 3+ years and a Master’s degree; or a PhD without experience in Chemistry, Biochemistry, Chemical Engineering or equivalent

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

The estimated base salary range for the Sr Engineer - Process Development role based in the United States of America is: $98,400 - $147,600. 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 [e-mail]. 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.