As a Sr. Manufacturing Excellence Engineer you will collaborate cross-functionally with Manufacturing, Quality, Process Engineering and other stakeholders to sustain and improve the compliant state of the first Next Generation Sequencer recognized by the FDA.
All About You
- Reports to Associate Director Dx Manufacturing within Manufacturing/Operations.
- Collaborate cross-functionally with QA, Manufacturing, Lifecycle Change Management (LCM) and extended R&D team to support product and process changes and improvements.
- Work with Site Quality, Software Quality, Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits.
- Collaborate with Manufacturing teams, Process Engineering and other stakeholders to identify opportunities for continuous improvement using Lean and Six Sigma principles and techniques.
- Acquire a solid technical understanding of the instrument manufacturing and quality processes.
- Support adherence to all manufacturing work instructions, SOPs, policies and procedures, including any department specific requirements in addition to accurate DHR and quality records.
- Directly supports Manufacturing, Quality and other stakeholders during Internal and External Audits.
- Assist in managing introduction of hardware/software configuration changes into manufacturing.
- Support maintenance of validated state under Site Validation Master Plan and recommends changes to Site Validation Master Plan as needed.
- Support validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.
- Completes hands-on activities in areas of: Non-Conformance Resolutions, Evaluation of Process Changes and Design Changes.
- Assists with determination of root cause, impact, and resolution of problems impacting production.
- Support development of procedures, test plans, test protocols and reports using sound scientific rationale.
- Support and occasionally lead CAPAs under the direction of Manufacturing and/or QA.
- Presents periodic updates to Managers and peers on key projects and action items.
- Coaches and assists manufacturing and other stakeholders with documenting non-conformances and process deviations.
- Assist with development and review of system/software requirements to ensure testability.
- Assist with documentation and resolution of deviations that occur in the support of the Manufacturing process.
- Supports complaint investigations and implementation of CAPAs, as needed.
- 5-8 years’ experience within an operations environment and a solid understanding of manufacturing processes in high-tech medical device manufacturing.
- Strong understanding and working application of FDA cGMP regulations and 21 CFR Part 820.
- Ability to provide guidance and training in the practical and risk based application of regulations and standards.
- Strong interpersonal and coaching skills are a must. Candidate should possess a high level of energy and drive that result in a team member that is self-directed with a proven track record of successes.
- Experience with LEAN/SixSigma with a mindset of continuous improvement is highly desired
- The candidate should possess excellent analytical and problem solving skills coupled with experience in project management
- The candidate should possess the ability to lead and influence without having direct authority.
- Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
- Knowledge and working application of validation principles and guidelines and industry best practice.
- Ability to communicate effectively across functions and organizational levels.
- Must be a highly collaborative team player with can-do-attitude.
- Intermediate Knowledge of Statistical Tools and Practical Applications – Sample Size, Hypothesis Testing, Design of Experiments.
- Experience performing FMEA and Risk Analysis.
- Ability to discuss technical topics with non-technical people.
- Proficiency with standard business software (MS Office/MS Project)
- Excellent verbal and written communication/documentation skills.
- Strong attention to detail.
- Experience with SAP/ERP, and Manufacturing Execution Systems is a plus
- Requires a B.S. degree or above in Engineering or Science. Experience in Medical Device manufacturing with Biotechnology industry experience is highly desirable. Lean manufacturing background is preferred.
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 858-246-8959. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf