Automation CSV Lead
•Today
| Hours | Full-time |
|---|---|
| Location | Henrico, VA 23238 Henrico, Virginia open_in_new |
About this job
Job Description
Job Description
Title: Automation CSV Lead
Site Location: Richmond, VA (REMOTE)
Work effort and locationYearOccupationLocation2026FulltimeRemote 2027FulltimeRemote2028Fulltimeonsite
Duration:
Desired Duration is 3+ years
Lilly Richmond Program Overview:
Lilly is constructing a new greenfield campus in Goochland County, Virginia focused on biologics and bioconjugate drug substance manufacturing. The site includes multiple manufacturing facilities, utilities, laboratories, administrative offices, and warehousing, with some drug product filling capability also included.
The Richmond Automation Program supports this construction effort and is currently in the Basic Design phase. The program is organized under a central Automation Program Office, with independent Automation Project Teams assigned to each facility. These teams are responsible for defining automation requirements, standards, and best practices, and for overseeing System Integrators who execute the detailed automation design, coding, and testing.
Purpose of the Role:
Provide leadership and be responsible for the setup and direction of the CSV deliverables of the automation solution for the program
Role Responsibilities:
Role Requirements:
Deliverables:
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
Site Location: Richmond, VA (REMOTE)
Work effort and locationYearOccupationLocation2026FulltimeRemote 2027FulltimeRemote2028Fulltimeonsite
Duration:
Desired Duration is 3+ years
Lilly Richmond Program Overview:
Lilly is constructing a new greenfield campus in Goochland County, Virginia focused on biologics and bioconjugate drug substance manufacturing. The site includes multiple manufacturing facilities, utilities, laboratories, administrative offices, and warehousing, with some drug product filling capability also included.
The Richmond Automation Program supports this construction effort and is currently in the Basic Design phase. The program is organized under a central Automation Program Office, with independent Automation Project Teams assigned to each facility. These teams are responsible for defining automation requirements, standards, and best practices, and for overseeing System Integrators who execute the detailed automation design, coding, and testing.
Purpose of the Role:
Provide leadership and be responsible for the setup and direction of the CSV deliverables of the automation solution for the program
Role Responsibilities:
- Interface with Subject Matter Experts, Site and Area Management, Quality Assurance, and other client resources for key information for validation projects planning
- Prepare CSV planning deliverables, such as Validation, Security, and Test Plans.
- Collaborate with CSV leads on other Lilly projects
- Support Validation efforts as per the Validation Plan and CSV document management plan expectations
- Support the generation of individual project CSV documents, such as Project Validation Plan, Test Plan, and Electronic Testing Templates and objects in Kneat
- Work collaboratively with equipment vendors and system integrator to ensure technical deliverables are compliant with CSV expectations, plans, and methods
- Take part in Supplier Assessments, Risk Assessments, and Data Integrity Assessments
- Recommend improvements for consistency or compliance in CSV deliverables
- Ensure CSV documents comply with corporate Quality Standards and Practices, local templates, and electronic document management system properties and practices
- Support good documentation of executed test cases in the electronic testing system, with both proactive education and post-execution troubleshooting, as guided by the document management plan and test plan
- Create reports, views, and queries in Change management, Electronic Document Management, and Electronic Test systems to support project tracking
- Develop spreadsheets/tools to analyze a large volume of validation artifacts
- Support all CSV documents associated with the change control in alignment with the CSV document management plan expectations
- Provide CSV mentoring and guidance for automation and other functional SMEs
- Build a strong relationship with the CSQA personnel and be proactively aware of and respond to shifts in CSQ expectations and practices
- Support onboarding, training, workload, attendance, and exits for validation personnel
- Anticipate validation needs and trends in support of customer systems' validated state
Role Requirements:
- BS in Engineering or equivalent preferred
- 10+ years working experience in CSV within the Pharmaceutical industry
- Previous Pharmaceutical Automation Large Project experience
- Exceptional teamwork abilities
- Electronic Document Management and Electronic Test Management experience preferred (Kneat)
- Attention to detail in complex tasks, strong Microsoft Office software skills, experience in maintaining multiple simultaneous projects, experience interpreting and applying corporate standards and practices, excellent communication skills, strong web-based applications and reporting skills, e.g., change management and document management systems
- Preferably, solid knowledge of GMPs, regulatory requirements, and computer system validation
- Excellent written and verbal communication skills for both technical and non-technical audiences
- Experience with DeltaV preferred
Deliverables:
- CSV planning documents
- Project-specific CSV documents
- Review and approval of equipment vendor and system integrator documentation
- Electronic Testing record implementation and maintenance
- Change management planning, implementation and maintenance
- Validation Artifact Analysis tool
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
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