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.Basic Function and Scope of the Position:As a Process Engineer at Illumina, you will lead cross-functional teams through new product and process transfer for in-vitro diagnostics and medical devices. You will provide technical leadership and operational support to process development and improvement efforts in a high-volume, multi-product manufacturing environment. Strong communication and leadership skills are essential for collaborating with R&D, Quality, Supply Chain, and Manufacturing teams. Your role is critical in ensuring the successful transfer of new products and processes into manufacturing and driving continuous improvements to deliver high-quality products to customers.These essential responsibilities require a self-starter, analytically-oriented process engineer who can provide technical leadership and operational support in a high volume, multi-product manufacturing environment. Tasks and Responsibilities:Participate and lead technical decision with cross-functional teams through new process and product transfer for in-vitro diagnostics medical devices, ensuring compliance with regulatory requirements (MDSAP, ISO 13485, 21CFR820, ISO 14971)Develop and optimize processes to address quality issues and drive continuous improvement, utilizing controlled experiments and technical recommendationsTroubleshoot production line issues related to yield, quality, and throughput, and implement corrective actions to improve product quality and efficiencyEstablish and improve operating processes and equipment specifications to ensure efficient and effective production of medical devicesDevelop and implement process control plans to monitor and improve process performance and reduce variationConduct process troubleshooting and root cause analysis to resolve manufacturing process issuesDevelop and maintain process documentation, including work instructions and manufacturing batch recordsCollaborate with cross-functional teams, including Manufacturing, Quality, R&D, and Supply Chain, to develop and implement process changesDefine technical requirements and procedures for manufacturing processesReasonable accommodations for additional tasks and responsibilities may be necessary based on business conditionsPreferred Educational Background:Bachelor of Science/ Bachelor of Engineering/ Masters or equivalent in Chemical, Biochemical, Biochemistry and/or Bio-related fieldPreferred Educational and Experiential Background:Bachelor of Science/Bachelor of Engineering/Masters or equivalent in Chemical, Biochemical, Biochemistry or a related field3-5 years of relevant experience, including research product development, project management, production support/sustaining, process development, design, scale-up, improvement, and validationExperience in lyophilization process is desirableExperience in biotech/pharmaceutical industries and FDA-regulated environments with cGMP knowledge preferredProficiency in chemical processes and analysesExcellent organizational skills and attention to detailAbility to collect, prepare, and present relevant information to influence decision-makingCompetencies:Excellent documentation skills for writing procedures and training manualsProficiency in basic computer troubleshootingStrong inter-departmental communication skills, including effective communication, facilitation, coaching, and negotiationProven ability to work independently and collaboratively in a team environmentExpertise in applying DOE techniques, Statistical Process Control, and Statistical analysis tools such as SPC, 6 Sigma, Risk Analysis, FMEA, and DOEAbility to analyze data and draw logical and rational conclusions, including experience with lyophilization processIllumina 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.
View Original Job Posting