Senior Process Development Engineer
Location: San Diego
Posted on: September 14, 2020
We are looking for a technical expert for our Consumables
Process Development and Transfer (cPDT) group. The cPDT group works
as an integral part of our Consumables Manufacturing process and is
tasked with new product introduction and increasing quality and
yield within our high-volume production environments.
This individual will be primarily accountable for process
development and transfer to Operations of RUO and IVD library
preparation, sequencing, and micro-array assay products. The role
ensured best-in-class product quality and optimized cost of goods
through proactive integration of risk-based design requirements,
performance testing controls, and manufacturing strategies into the
product development process. Additionally, this person will lead as
appropriate enhancement of on-market products and enhance/develop
risk-based design and transfer processes within cPDT.
This position for the Operation's team will enable the development
of Illumina's core technologies and applications in one of the most
technically innovative spaces in industry. The ideal candidate will
have experience in diagnostic process development to ensure and
enable the transfer, launch, and on market support of complex
- Lead and conduct laboratory work and experiments per assigned
- Establish process requirements to meet product
- Collaborate and guide new product introduction teams throughout
the stages of product development process (PDP) in order to:
- Act as a liaison between development and manufacturing
- Lead and guide the construct and execution of controlled
experiments (including DOEs, gauge R&R studies) to
develop/optimize manufacturing ready production workflows or test
- Evaluate manufacturing assessment and/or develop new
manufacturing processes for new products or improvements
- Provide technical oversight and coordination of development and
pilot lot builds within the Pilot Plant production area supporting
multiple projects and initiatives
- Help develop, review and execute analytical test methods to
support process development activities, process scale up studies,
change evaluations, and other Pilot Plant related activities.
- Support product characterization activities and method
development activities as needed, including recommending materials
for reliable performance (material compatibility and availability)
and manufacturing scalability
- Ensure successful transfer of knowledge into manufacturing and
the sustaining support teams
- Monitor, trend and analyze results from development and pilot
lots during the NPI process; track off-targeted production outputs,
troubleshoot/perform root cause analysis, and make technical and
compliance related recommendations as required.
- Partner with support functions to effectively plan and lead
implementation of manufacturing continuous improvement initiatives
as it relates to sustaining products; examples include but are not
- Scale up projects to meet anticipated business needs,
- Identify and quality new/changes to materials meeting product,
process, QS and regulatory requirements
- Introduction of new automation equipment and/or changes to
existing manufacturing processes.
- Present clear and concise written and oral communications to
colleagues and supervisors, lead and participate in technical
meetings, and provide recommendations based on results.
- Author technical documents, such as plans/protocols,
engineering reports, SOPs, or other manufacturing related
- Work experience in production, pilot plant, and/or product
development following GMP best work practices and techniques is
- Work experience with NPI projects, design change control
programs, and having an understanding of product lifecycle
- Experience with DOE techniques, statistical analysis, and
statistical process controls.
- Experience with various manufacturing process workflows,
automation and equipment used to support production of multiple
- Demonstrated ability to accomplish goals while working across
departments is required.
- Demonstrate capability to support the process and/or test
methods development activities.
- Demonstrate ability to problem solve, provide technical
evidence for support and make decisions.
- Ability to communicate effectively and build strong
relationships across multiple departments.
- Ability to work in fast-paced environment; easily adaptable to
- Highly Desired:
- Experience in editing or troubleshooting process workflows,
production lines and automation equipment
- Knowledge of various laboratory techniques, may include but not
limited to, analytical methods (e.g. HPLC, LC-MS, and
spectrophotometry), nucleic acid-based techniques (e.g. PCR, array
hybridization, etc.) and biochemical (enzymatic) assays.
- Knowledgeable of electronic change management and document
management systems; knowledgeable of ERP/MRP systems.
- Knowledgeable of ISO 13485, ISO 147901, 21 CFR 820 / 11, or
other regulatory requirements and its application
B.S./M.S./ PhD in Biochemical Engineering, Bioengineering,
Biotechnical Engineering, Bioinformatics, Biological Sciences,
Materials Science or Physical Chemistry or equivalent disciplines
with: 2-4+ years of industry experience with a PhD, 5-7+ years of
industry experience with a MS/BS
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.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 require accommodation to complete the
application or interview process, please contact
firstname.lastname@example.org. To learn more, visit:
Keywords: Illumina, San Diego , Senior Process Development Engineer, Engineering , San Diego, California
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