Staff Engineer - Process Development

Illumina San Diego, CA
Position Summary:

We are looking for highly driven and talented Process Engineers to join our growing Life Cycle Management (LCM) group. The LCM group works as an integral part of our Reagents Manufacturing process and is tasked with increasing quality and yield within our high-volume production environments. These highly collaborative, flexible and dynamic individuals provide technical and operations leadership to New Products Introduction (NPI) area.Additionally, these teams will partner cross-functionally with R&D, Quality, Production and other departments to develop processes for new products, as well as sustain and improve processes for existing products.

Responsibilities:

* Provide technical leadership in production processes and in the making of consumable products used in genomic sequencing and microarray products

* Collaborate deeply with others to resolve production line issues related to yield, quality, and throughput.

* Represent operational needs on product development teams.

* Construct, execute, evaluate, and make recommendations on controlled experiments (including DOE's) to optimize processes to address yield and quality issues, reduce costs, define requirements/specs, and drive implementation of solutions to meet goals.

* Utilize strong production and process change management practices to drive improved quality or production performance.

* Author technical documents, such as engineering reports, test protocols, validation documents or changes to existing documentation, to support product manufacturing process documentation requirements.

* Analyze, trend and monitor process test results, issue reports, and make technical recommendations

* Perform root cause analysis investigation using RCA tools (such as 8D, 7-Step, 5 Why's or model based problem solving, etc) together with sound science and data analysis to make technical and compliance-related recommendations and decisions.

* Lead or support process deviation remediation and non-conformances/CAPA's with supporting technical documentation or reports.

* Serve as subject matter expert on manufacturing processes and equipment to facilitate efficient new product transfer and launches.

* Assist manufacturing facilities in completing required technical documentation to enable successful product launches.

* Utilize expertise in process engineering methodologies, such as FMEA, SPC, Gauge R&R, Critical Parameter Management, to measure and improve process capability and robustness.

* Facilitate and support product and process continuous improvement activities.

* Lead the technical direction of a project team including driving execution to project deliverables and providing risk mitigation recommendations to meet project milestones.

* Facilitate or support the transfer of manufacturing and QC processes from development through scale-up to volume production in a regulated manufacturing environment.

Requirements:

Previous work experience in a similar role in one or more of the biotech, diagnostic, pharmaceutical, medical device or semiconductor industries.

High level problem solving and reasoning skills and ability to independently lead investigations/resolve technical problems.

Extensive experience in transferring products and processes from development to manufacturing.

Ability to identify risks and strategize activities appropriately.

Ability to learn new technologies/processes quickly and determine impacts to multiple operations-related business areas (e.g. Supply Chain, Quality, Manufacturing)

Experience in production support, process development and project management skills (plan/prioritize activities, resources, and budget) is required.

Willingness to work outside your primary area of educational discipline or area of current expertise.

Strong interpersonal communication skills and the ability to positively influence and be influenced by others and build relationships in a collaborative environment. Able to manage external relationships (e.g. vendors, contractors, collaborators) and maintain confidentiality.

Well-developed documentation and technical report writing skills.

Comfortable working in areas of high ambiguity and complexity in a fast-paced environment.

Demonstrated ability to accomplish goals while working across departments is required.

High level of computer skills are required.

Highly Desired:

Intermediate level programming knowledge is strongly desired.

Experience with large data sets and data mining techniques would be a plus.

Experience working in an ISO13485, GMP or FDA regulated environment.

Experience expanding production capacity and automating processes.

Experience with high volume production in a high-tech consumables industry.

Experience with liquid handling and filling technologies.

Automated filling experience with Hamilton or Tecan is a plus.

Experience with fluorescence imaging technologies.

Experience with chemical processes (preferably organic).

Experience applying statistics, Statistical Process Control, and Design of Experiments

Experience of analytical methods (e.g. HPLC, LC-MS, SDS Page), enzymatic assays or other biological techniques.

Experience working with SAP and MES

Experience of Lean/Six Sigma/DFM/DMAIC/FTA/MSA

Education:

B.S./M.S./ PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics or MS/PhD in Materials Science or Chemistry, with at least 5 years of relevant experience in production support/sustaining and/or process development, design, scale-up, improvement and validation.

Experience/Education:

Typically requires a minimum of 8+ years of related experience with a Bachelor's degree and Master's degree; or a PhD with 3+ yrs experience; or equivalent work experience

Illumina believes that everyone has the ability to make an impact, and 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. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf