Sr Engineer, Product Life Cycle at Illumina, Inc.
Posted in Architecture 14 days ago.
This job brought to you by eQuest
Location: Madison, Wisconsin
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.
We are looking for a driven individual to join our enzyme manufacturing team as a product manager and thereby provide leadership in a variety of technical and application areas.
In this role you will be responsible for working closely with fermentation, purification, formulation, QC, QA, Process Development, and Laboratory Support to in a variety of areas that support the production of enzyme reagents. These responsibilities may include any of the following:
Operational readiness: Work with the Manufacturing Sciences team to identify high impact process limitations, sustaining activities to improve performance or yield, and propose process or specification changes that will improve performance or yield. Maintain understanding of current readiness, including production process maps, yield, cycle time, range of performance, and known production and performance risks. Collect and communicate lot-by-lot activity, contaminations, yields, and stability data, etc. Participate in material reviews.
Production history and current state: Track production history, process change history, and performance history for each product and assess how the specifications correlate to finished goods performance. Track the process difference between RUO and Dx versions of each product. Maintain relevant product data in master product files including IP reviews, sequence data, design history, and engineering documents. Complete technical risk assessments to support non-conformance dispositions.
Product Configuration: Execute new and maintain current part configurations, including part numbers, BOMs, routings, etc. Communicate “where-used”
New Product Introductions: Respond to information requests from Core Teams for enzyme or kits. Represent Madison Ops as needed at Core Team/PDP meetings and readiness reviews. Monitor status of Madison Operations activities during PDP process
Operational Excellence: Communicate to production teams where and how each product is used in company finished goods and customer workflows. Ensure specifications are aligned with product requirements, and if not, identify gaps and propose projects designed to address the gaps.
Change Control Project Management: Working with manufacturing and QC teams, prepare change control documentation (e.g. proposals, engineering documents, risk assessments, testing and qualification protocols, etc.) to support proposed process or testing changes for current and new enzymes. Assess risk and impact of any change on product performance. Develop relationships with product teams to ensure the smooth communication of proposed changes and the completion of necessary performance testing. Ensure that process changes have been properly incorporated into work instructions by the document revision personnel, and report out regularly on progress. Review planned deviations to ensure that they can proceed without CCB review.
- 5 or more years in a technical product management or product engineering role in the biotechnology or pharma industries.
- Demonstrated knowledge of Illumina core technologies.
- Ability to accurately execute complex projects in an efficient and timely manner.
- Ability to think critically and demonstrated troubleshooting and problem solving skills.
- Self-motivated and willing to accept temporary responsibilities outside of the initial job description.
- Excellent interpersonal, verbal, and written communication skills.
- Comfortable in a fast-paced small company environment with minimal direction.
- Ability to adjust workloads based upon changing priorities.
- B.S., M.S., or Ph.D. in Biochemistry, Chemical Engineering, or a related field.
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 858-255-5081. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf