Associate Director - Laboratory Systems Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Laboratory Systems Lead

Houston API Manufacturing Site — Generation Park, Houston, TX

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Lilly is investing $6.5 billion to build a new state-of-the-art active pharmaceutical ingredient (API) manufacturing site at Generation Park in Houston, Texas. The new site will produce APIs for small-molecule medicines for cardiometabolic health and will be built with the latest high-tech equipment, highly integrated and automated manufacturing systems, and a focus on minimizing environmental impact. This is a once-in-a-lifetime opportunity to help build and start up a new site.

What You'll Be Doing

The Lab Systems Lead owns the connection of laboratory equipment to the site's lab applications and the integration of those applications at the Houston site and leads the contract and internal team that delivers and supports that work.

You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence through technology and enables the making of medicine "with safety first and quality always.

As Lab Systems Lead, you will lead the integration lab instruments and equipment to the site's core lab applications including LabVantage, MODA, Binox, WinkQCL, NuGenesis and Veeva. Global teams mainly support these applications, so you will be the site's technical point of contact and work with those teams to bring local equipment and data flows into them. You will support the initial validation of the site's lab systems and connected instruments, with risk-based, right-sized validation and a strong focus on data integrity.

You will lead a team of contract resources and, as the site grows, internal Tech at Lilly team members. You will set priorities, assign and review work, mentor technical talent, and act as the escalation point for lab system issues. You will partner closely with laboratory personnel, site and global IT, Computer System Quality Assurance (CSQA), site Quality Assurance, the Global Quality Laboratory Network, and external vendors.

Your Primary Responsibilities

Equipment connectivity and integration

- Connect lab instruments, stand-alone equipment, and edge devices to LabVantage, MODA, and other lab applications, including instrument software, interfaces, and data flows.

- Design, build, test, and maintain integrations among LabVantage, MODA, WinkQCL, NuGENESIS, Binox, Veeva, and related site and business systems, using agile methods.

- Work with lab personnel to translate QC business processes into connectivity and integration requirements.

- Act as the site technical point of contact for the global teams that support these applications: raise site needs, coordinate changes, upgrades, and releases, and align on standards.

- Troubleshoot connectivity and integration issues, implement fixes, and minimize disruption to lab activity and data integrity.

- Evaluate new lab equipment and technologies for connectivity and integration fit, with site Tech at Lilly SMEs.

- Ensure Lilly information assets are protected from malicious content and that access is limited to authorized personnel.

Validation, compliance, and data integrity

- Support the initial validation of lab systems, integrations, and connected instruments, including computerized analytical instrument qualification (IQ/OQ/PQ) and CSV deliverables across GAMP 5 software categories, working with CSQA and CSV service providers.

- Apply risk-based, right-sized validation approaches to equipment connections and integrations.

- Partner with site data integrity (DI) SMEs on audit trail management, workstation security, and connecting stand-alone equipment.

- Support change control, investigations, deviations, and CAPAs in Veeva as they relate to lab systems and connected equipment.

- Support internal and external audits and inspections for lab systems.

- Maintain current technical documentation and ensure compliance with ALCOA+, FDA, and GMP requirements.

Team leadership

- Lead contract resources, and internal team members as they are added, in connecting, integrating, and supporting lab equipment.

- Set priorities, assign and review work, and plan resources against production schedules, shutdowns, and project timelines.

- Coach and mentor technical team members and develop training and local practices for the team.

- Direct CSV third-party providers and other vendors, including articulating needs and reviewing deliverables.

- Prioritize and escalate issues effectively and represent lab systems with global and site stakeholders.

Your Basic Qualifications

- Bachelor’s degree in IT, Engineering, or related technical field
- 8+ years of relevant experience in laboratory or manufacturing IT, instrument connectivity, or systems integration in a regulated (GMP) industry, including experience supporting computer system validation.

- Working knowledge of CSV, GAMP 5, GMP, and data integrity principles, and the ability to apply risk-based validation.

Additional Preferences

- Experience with LabVantage, MODA, WinkQCL, NuGENESIS, Binox, or Veeva, or comparable QC laboratory systems.

- Experience connecting lab instruments and edge devices to LIMS and other lab applications.

- Experience building integrations between enterprise and laboratory systems (for example APIs, middleware, or file-based interfaces).

- Experience working with global support teams, or in a global organization.

- Experience leading or directing contract or vendor teams and mentoring technical team members.

- Experience with new system implementations, ideally in a greenfield or new-site setting.

- Agile delivery experience.

- Understanding of cybersecurity concepts and best practices for lab IT technologies.
- Demonstrated ability to understand quality control business processes and convert them into IT requirements and solutions.

- Strong analytical and problem-solving skills to resolve complex technical issues in lab systems, instrument connections, and integrations.

- Ability to prioritize and escalate issues, and to manage multiple tasks in a fast-paced environment.

- Excellent communication and interpersonal skills to build relationships with stakeholders, including global teams, and explain complex technical concepts.

- Demonstrated learning agility and curiosity.

Other Information

- Role is based onsite at Houston, Texas — API Manufacturing Site.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is
$129,000 - $189,200

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Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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