Computer System Validation Csv Jobs in Indiana (NOW HIRING)

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Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

Overview:

The Process Control and Automation Engineer is responsible for the development, implementation, improvement, verification, and qualification of process control and automation solutions. This includes all activities necessary to support automation solutions in production, as well as area-engineering initiatives such as commissioning, qualification, process improvements, solution enhancements, and troubleshooting.

The PCAE - Application Enhancement (PCAE-AE) focus area is responsible for managing and implementing hardware and software application upgrades, including control strategies, recipes, and process data collection models, along with supporting validation, qualification, and verification of those deliverables.

Responsibilities:

• Manage and implement HW/SW application upgrades and updates, including control strategies, recipes, and process data collection models

• Support validation, qualification, and verification of application deliverables

• Maintain up-to-date documentation packages for all applications

• Work safely in accordance with all HSE standards

• Perform all activities in compliance with GMPs and applicable procedures

• Stay closely aligned with the process team as an active, participating member - understanding priorities, issues, and objectives, and responding to team decisions

• Develop system requirements and designs

• Manage and develop code in a GMP-compliant manner

• Deliver projects on time and execute changes that keep systems reliable, current, and compliant

• Appropriately prioritize activities to maximize overall business impact

• Understand and apply GMP concepts to influence procedure development

• Contribute to continuous improvement efforts, including equipment reliability

• Perform other tasks as assigned by supervisor

Basic Requirements:

• Bachelor's degree in Engineering, Computer Science, or a related field

• 10+ years of experience as a Process Automation Engineer or Process Engineer

• 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 Preferences:

• Computer System Validation (CSV) experience is desirable

• Strong interpersonal and communication skills with the ability to work effectively in a team environment

• Willingness to learn areas outside of core automation responsibilities

• Ability to develop expertise in production processes, equipment-specific code, and control system technologies (software, hardware, and field instrumentation)

• Automation Platform Experience:

  • Emerson: DeltaV Operator, Live, Batch, AMS, Historian, Simulate, Simulate Pro, MIMIC Simulation Platform

  • Rockwell: Studio 5000, Logix, FactoryTalk SE/ME/Asset Center, Historian

  • AVEVA PI: PI Historian, PI Vision, Event Frameworks

  • Johnson Controls: Metasys VE Logmate

• IT Platform Support Experience:

  • Server administration and health monitoring

  • LAN/network support and troubleshooting

  • Virtual hardware setup and administration

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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