- Master's Degree
- Bachelor's Degree
- Molecular Biology
- Lean Manufacturing
- FDA Regulations
- Laboratory Experience
- Organic Chemistry
We are looking for a driven, talented Process Engineer / Scientist to join our growing Manufacturing Technical Operations (MTO) group. The MTO group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our production environments. This individual will provide technical support to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.
Provide technical leadership in the production and analysis of nucleotides, modified triphosphates, and/or oligonucleotides, in a regulated manufacturing environment.
Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products
Represents Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams.
Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.
Analyze, trends, monitors and updates Manufacturing KPIs and metrics.
Support non-conformances/CAPA’s through providing technical evaluations and investigations.
Support continuous improvement and sustaining activities.
Aid in the selection of appropriate components and vendors in area of responsibility.
Support the transfer of manufacturing processes between manufacturing locations.
Facilitate productive cross-site and cross-functional relationship between manufacturing sites.
Able to plan and prioritize assigned tasks and activities with minimal guidance.
Execution of tasks with guidance from project lead or manager.
Provides technical decisions in own area of responsibility.
Tracks component COGS and associated project expenses
Demonstrated ability to make oligonucleotides, nucleotides, and/or associated subassemblies
Manufacturing experience of organic synthesis is highly desirable
Working knowledge and experience of automated synthesis, preparative and analytical chromatography. LC-MS and ability to interpret NMR is desirable.
Experience in process support and development in a GMP environment
Strong analytical, problem solving, troubleshooting, and root cause analysis skills
Strong interpersonal, verbal and written communication skills required
Must be detail oriented
Strong understanding of GMP
Experience with standard laboratory practices
Strong computer skills are required. Programming knowledge is a plus.
Experience with SAP or equivalent ERP system
Experience working in an ISO 13485 or FDA regulated environment is desirable
Experience with lean manufacturing tools and principles is a plus
Experience with statistics, Statistical Process Control and DOE techniques is desirable
MS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 1+ years of related experience
BS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 3+ years of related experience
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: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf