Senior Validation Manager

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:

Direct and drive validation activities for all Consumables platform, NPI activities and automation system to achieve a high level of manufacturing efficiency. Lead improvement initiatives on validation procedure and processes by working with cross functions team. Plan strategy for team to grow capabilities and value to enable fast turn around for protocol and validation report closure.

Position Responsibilities:

• Lead a team of Validation engineers to ensure validation protocol, quality and projects are delivered on time
• Provide advice and coaching in the resolution of validation challenges and issues, promote unity and cooperation to move thing forward
• Define and ensure Key Performance metrics on validation work under her ownership are monitor and review regularly
• Lead validation improvement initiatives and influence cross functions including Global team to buy in
• Strategize work groups OPEX spending and budgeting as well as manpower planning to support NPI and sustaining (RUO/Dx)
• Provide leadership to consult, advice and leverage practices to other departments performing validation activities
• Support in internal and external audits, QMR and oversee Site VMP.
• Promote and enhance cross-site and cross-functional relationship, keeping communication open and seek to understand constraints
• Manage team development through training, coaching and career mapping and career development, hold accountability to do the right thing

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Bachelor's Degree in Engineering or Science or equivalent field of study
• Minimum 12+ years of relevant work experience in Validation, with 3-6 years of people management experience
• Knowledge in ISO13485, MDSAP & MDDAP
• Strategic thinking with abilities to make recommendation and improvements
• Managers at this level may become involved in elevated issues arising from daily activities
• Ability to apply broad management, functional expertise/knowledge to subordinates managers and staff members
• Will have developed key relationships with important customers and suppliers

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.