Computer System Validation Manager Jobs in 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 around the world 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. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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 40,000 employees around the world 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. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the site technical team for the [MH1]startup of a greenfield manufacturing site, and the successful candidate will help to build the processes, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Responsibilities:

ThePrincipalAutomationEngineer-Computer System Validationisamid-levelautomationengineeringposition thatrequires adeep understanding of process automation systems,Lilly'scomputer system validation practices,cGMP standards related to computer systems, and data integrityas they relate to pharmaceutical manufacturing.

This rolewillsupportthe design and delivery ofprocessautomationsystemsincluding requirements,verification plans, validation plans, and strategies for overall computer system validation.

This role will also be integral in the developmentof computer system validation plans forprocess automation systems (DCS and PLC based), Building Management Systems,and supporting systems including data historians andother central automation platforms. Lilly Houston is part of Lilly'sDrug Substance(Active Pharmaceutical Ingredient) network.

During the design and delivery of the project this role will beintegrated into the corporateautomationteam GPACE (Global Process Automation & Control Engineering)and then transition fully to a site-based process team position.During delivery, this role will collaborate withLilly Quality,A&E firms,system integrators,andcorporate and siteengineering peers.

Post-projectdelivery, this role will support GMP manufacturing operationsin the central engineering functionsupporting one or more process teams.Thisrolewill requiresignificant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturingsitethrough start up.

Key Deliverables:

• Champion astrongsafety culture,mentorand coach others,andutilizeengineering and automation fundamental principles in design and problem solving.
• Become a subject matter expert on Lilly Quality Standards & Procedures that apply to Process Automation systems including requirements, design, and testing with a focus on the API / Drug Substance network
• Collaborate with Lilly's Quality organization, Corporate Engineering, and Global Facilities Delivery to develop Computer System and Process Automation qualification and testing strategies.
• Lead and direct a contingent workforce team tosupport multiple project delivery workstreams on computer system validation.Ensure CSV documentscomplywithCorporate Quality Standards and Practices, local templates, and electronic document management systemproperties.
• Participate inbasicand detaileddesignthat also includes staffing, statements of work, supplier management, and deliverystrategiescomputer system validation.
• Develop and build capabilities within the Houston site automation team.
• Support the development ofsite proceduresrelated tocomputer system validation and administration practices.
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems areappropriate forintendedpurpose.

Basic Qualifications:

• Bachelor's degree in engineeringor related applicable Science degreerequired.
• 3+ years of experience incomputer system validation.
• 3+ years of experience in process automation.
• 3+ years of experienceinpharmaceuticalmanufacturing.Other manufacturingexperiencewill be considered (Food & Beverage and Nuclear).

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Experience with automation platforms including Rockwell Automation and EmersonDeltaV.
• Strong analytical, writing,and critical thinking skills.
• Experience withKneatValidation software, Veeva Vault,or similar package.
• Ability to collaborate with others.

Additional Information:

• Potential for travel (less than 20% - could be domestic and/or international)to support system,factory acceptance testing, and training.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

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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