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Director Computer System Validation Csv Jobs in Indiana

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$97.80K - $134.30K/yr

... Computer System Validation (CSV) activities, including MES qualification and data integrity assessments. • Work closely with IT to implement OT solutions in an integrated and secure network.

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$94.10K - $129.20K/yr

... to Computer System Validation (CSV) activities, including MES qualification and data integrity assessments. · Work closely with IT to implement OT solutions in an integrated and secure network.

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN

$94.10K - $129.20K/yr

... to Computer System Validation (CSV) activities, including MES qualification and data integrity assessments. · Work closely with IT to implement OT solutions in an integrated and secure network.

CAI

Computer Systems Validation Engineer

Indianapolis, IN

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Lilly

Associate Director Data and Systems QA

Lebanon, IN

$123K - $180.40K/yr

Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in ... Provide quality guidance, technical support and recommendations to efficient CSV and data integrity ...

Elanco

Process Automation Engineer

Clinton, IN · On-site

Knowledge of computer system validation (CSV) and change control practices * Experience supporting Operational Technology (OT) lifecycle strategy and system upgrades * Demonstrated ability to deliver ...

New

Elanco

Engineer, IT Quality Management

Indianapolis, IN · Hybrid

$68.80K - $88.90K/yr

A working knowledge of current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), and Computer System Validation (CSV) principles. What will give you a competitive edge ...

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Data Management specialist - Aveva PI

Beth Page tech

Indianapolis, IN • On-site

Contractor

Posted 29 days ago

Job description

Job Title: Data Management Specialist – Aveva PI

Location: Indiana, IN (Hybrid)

Role: Contract

Duration: 12 Months

Key Responsibilities:

  1. Collaborate with site teams, Data Integrity champions, Engineering Tech Centres, and
  2. Technical Services to define data architectures and models
  3. Participate in the overall design of scalable and compliant data architecture
  4. Develop specifications and scope documents for data management initiatives
  5. Lead the execution and delivery of data management projects
  6. Oversee and coordinate with System Integrators executing data projects
  7. Work with technical departments to design process and asset templates supporting data
  8. models
  9. Identify equipment-specific data requirements for operations, maintenance, and
  10. reporting
  11. Ensure alignment of data management with information security protocols in
  12. collaboration with the Foundry Automation Technical Office
  13. Partner with Automation Project teams to integrate data solutions with existing system
  14. architecture and schedules
  15. Align data management efforts with Digital/MES workstreams
  16. Report progress, challenges, and support needs to the Foundry Automation Program
  17. Manager
  18. Address and resolve technical queries from system integrators
  19. Contribute to the creation of effective testing strategies for system validation

Basic Qualifications: 
 

  1. Bachelor’s degree in Engineering
  2. 8+ years of data management experience in the pharmaceutical industry (API/bulk
  3. manufacturing preferred)
  4. Strong hands-on experience with Aveva PI, including:
  5. PI site infrastructure, data archive, and interfaces
  6. PI Asset Framework (Elements, Analyses, Event Frames, Notifications)
  7. PI Vision for dashboards and visualization
  8. Strong knowledge of GMPs, regulatory requirements, and computer system validation
  9. (CSV) principles
  10. Excellent verbal and written communication skills for both technical and non-technical
  11. audiences
  12. Proven ability to work collaboratively in cross-functional teams
    Preferred Qualifications:
  13. Experience integrating Aveva PI with automation systems (e.g., Emerson DeltaV Rockwell)
  14. Familiarity with OT systems and integration platforms (e.g., KepserverEx, MQTT message brokers such as HiveMQ)
  15. Experience with Logmate or equivalent alarm management systems
  16. Involvement in large-scale pharmaceutical automation programs/projects