All About Us
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. We 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. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.
This position requires an individual who must work with minimal supervision to manage change and configuration activities of products from inception through end-of-life. This person will join a dynamic, fast paced organization supporting both new product development teams, as well as sustaining commercial operations. This person is also responsible for compiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global business systems. In addition to product configuration and change activities, tasks include support and iteration of MES models, management of Engineering Change Requests and Change Orders (ECRs/ECOs), development and maintenance of Bills of Materials (BOMs), and identification and participation in product and process improvements supporting business initiatives.
All About You
- Support and iterate models in MES to develop and optimize manufacturing process flows
- Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing
- Engage Subject Matter Experts (SMEs) to assure change and configuration documentation includes required information, such as supporting rationale, relevant documentation, and appropriate implementation strategies and validation.
- Support maintenance and accuracy of engineering and manufacturing Bills of Materials (BOMs), and other product documentation.
- Support effective life cycle management on part numbers from inception through end-of-life
- Create and process change orders and change requests in accordance with established procedures
- Monitor changes throughout the change management process to ensure accurate and speedy processing
- Review and monitor implementation activities to ensure the change has been completed properly
- Responsible for the accuracy of system data through process evaluation and validation
- Supports creation and maintenance of intra-departmental policies and procedures
- Develop and maintain product and process configurations and implement efficient and effective solutions in PLM and ERP. Understand implications of PLM/ERP changes to downstream cross functional areas and systems
- Identify, execute, and support process improvement initiatives of varying complexity engaging global, cross-functional support
- Able to work independently and requires minimal guidance to perform required tasks
- Work with peers and/or subordinates to ensure timely completion of projects and tasks
- Take initiative to develop and implement new processes to strengthen data accuracy or enhance efficiency
- Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- A minimum of 5 years related manufacturing environment experience required; preferably GMP
- A minimum of 5 years experience in project management, configuration management, operations, and/or quality departments within a regulated environment, preferred
- Ability to convert process flows into automated workflow models
- Experience in Medical Devices and/or Pharma Mfg with the ability to map business requirements with manufacturing IT applications
- Hands-on experience with 3rd Party interfaces that are commonly interfaced with MES application like ERP, PLM, LIMS, Equipment, etc.
- Should have a fair understanding of computer system and manufacturing validations
- Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP desirable
- Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
- Product Lifecycle Management (PLM) experience, SAP desirable
- Working knowledge of ISO 13485 and cGMP requirements strongly desired
- Proficient in use of Microsoft Office (Word, Excel, Outlook, Powerpoint, Visio)
- Flexible, able to adapt quickly to change.
- Experience working with teams across multiple functions
- High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
- Excellent communication skills both verbal and written
- Bachelor’s Degree in science, engineering discipline, or related field required
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.