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:
The Process Engineer at Illumina will lead cross-functional teams in the transfer of new products and processes for in-vitro diagnostics and medical devices. This role provides technical leadership and operational support for process development and improvement 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 to ensure successful process transfers and continuous improvement of high-quality products.
Position Responsibilities:
- Lead technical decisions within cross-functional teams for new product and process transfers, ensuring compliance with regulatory standards (MDSAP, ISO 13485, 21 CFR 820, ISO 14971).
- Develop and optimize processes to address quality issues and drive continuous improvement through controlled experiments and technical solutions.
- Troubleshoot production line issues related to yield, quality, and throughput, implementing corrective actions to enhance efficiency and product quality.
- Establish and improve operating procedures and equipment specifications for efficient medical device production.
- Develop and implement process control plans to monitor and enhance process performance, reducing variation.
- Conduct root cause analysis and resolve manufacturing process challenges.
- Maintain comprehensive process documentation, including work instructions and manufacturing batch records.
- Collaborate with Manufacturing, Quality, R&D, and Supply Chain teams to implement process changes effectively.
- Define technical requirements and procedures for manufacturing processes.
- Perform additional tasks as needed to meet business requirements.
Preferred Educational Background:
- Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field.
Preferred Experience and Skills:
- 3–5 years of experience in areas such as product development, project management, production support, process development, design, scale-up, improvement, and validation.
- Experience with lyophilization processes is highly desirable.
- Familiarity with biotech or pharmaceutical industries and FDA-regulated environments, including cGMP knowledge.
- Proficiency in chemical processes and analysis.
- Excellent organizational skills and attention to detail.
- Ability to collect, analyze, and present information effectively to influence decisions.
Competencies:
- Strong documentation skills for writing procedures and training manuals.
- Proficiency in computer troubleshooting and data analysis.
- Exceptional communication, facilitation, coaching, and negotiation skills across departments.
- Proven ability to work independently and collaboratively in a team setting.
- Expertise in applying statistical techniques, including DOE, SPC, Six Sigma, FMEA, Risk Analysis, and other statistical analysis tools.
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.
