Strong knowledge of GMPs, regulatory requirements, and computer system validation * (CSV) principles * Excellent verbal and written communication skills for both technical and non-technical ...
Quick apply
Strong knowledge of GMPs, regulatory requirements, and computer system validation * (CSV) principles * Excellent verbal and written communication skills for both technical and non-technical ...
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.
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.
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.
Quick apply
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.
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.
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.
... 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 ...
Quick apply
... 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 ...
Computer Systems Validation Engineer
$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 ...
Computer Systems Validation Engineer
$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 ...
... 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 ...
... 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 ...
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 ...
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 ...
Head of Process Engineering Indianapolis - Controls
$79.80K - $103.20K/yr
Verifiable practical experience with GAMP 5, Computer System Validation (CSV), and data integrity (21 CFR Part 11) in the regulated medical technology or pharmaceutical environment. * Routine ...
Head of Process Engineering Indianapolis - Controls
$79.80K - $103.20K/yr
Verifiable practical experience with GAMP 5, Computer System Validation (CSV), and data integrity (21 CFR Part 11) in the regulated medical technology or pharmaceutical environment. * Routine ...
Advanced knowledge of GxP and GAMP Computer System Validation (CSV)in regulated environments. * Strong critical thinking, problem-solving, and decision-making skillsin technical and business ...
Advanced knowledge of GxP and GAMP Computer System Validation (CSV)in regulated environments. * Strong critical thinking, problem-solving, and decision-making skillsin technical and business ...
Head of Process Engineering Indianapolis - Controls
Indianapolis, IN · On-site
$79.80K - $103.20K/yr
Verifiable practical experience with GAMP 5, Computer System Validation (CSV), and data integrity (21 CFR Part 11) in the regulated medical technology or pharmaceutical environment. * Routine ...
Head of Process Engineering Indianapolis - Controls
Indianapolis, IN · On-site
$79.80K - $103.20K/yr
Verifiable practical experience with GAMP 5, Computer System Validation (CSV), and data integrity (21 CFR Part 11) in the regulated medical technology or pharmaceutical environment. * Routine ...
Solid understanding of GMP, regulatory requirements, and computer system validation (CSV) principles. * Excellent written and verbal communication skills, for both technical and non-technical ...
Quick apply
Solid understanding of GMP, regulatory requirements, and computer system validation (CSV) principles. * Excellent written and verbal communication skills, for both technical and non-technical ...
Associate Director Data and Systems QA
$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 ...
Associate Director Data and Systems QA
$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 ...
The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists. Key Responsibilities: * Lead and execute CQV ...
Quick apply
The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists. Key Responsibilities: * Lead and execute CQV ...
SR. CSV Specialist
Indianapolis, IN · On-site
The Senior Computer Systems Validation Specialist focused on Building Management Systems to support a regulated pharmaceutical manufacturing environment. The specialist will support a Site Automation ...
Quick apply
SR. CSV Specialist
Indianapolis, IN · On-site
The Senior Computer Systems Validation Specialist focused on Building Management Systems to support a regulated pharmaceutical manufacturing environment. The specialist will support a Site Automation ...
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
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
Engineer, IT Quality Management
Indianapolis, IN · On-site
$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 ...
Engineer, IT Quality Management
Indianapolis, IN · On-site
$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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Internship Computer System Validation Csv information
What are the key skills and qualifications needed to thrive as an Internship Computer System Validation (CSV) specialist, and why are they important?
To thrive as an Internship Computer System Validation CSV specialist, you need foundational knowledge in computer science, life sciences, or engineering, along with an understanding of regulatory standards like GxP or FDA 21 CFR Part 11. Familiarity with validation documentation, software testing tools, and quality management systems is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting requirements and collaborating with cross-functional teams. These skills ensure compliance, data integrity, and the successful validation of computerized systems in regulated environments.
What are some typical responsibilities for an intern in Computer System Validation (CSV), and how do they contribute to the overall validation process?
As a Computer System Validation (CSV) intern, you can expect to assist with tasks such as reviewing and drafting validation documentation, executing test scripts, and collecting evidence to ensure compliance with regulatory requirements. You may also support the maintenance of validation records and participate in team meetings to discuss project progress or findings. These responsibilities are crucial in ensuring that computer systems used in regulated industries, like pharmaceuticals or healthcare, function as intended and meet quality standards. Working closely with senior validation specialists, you'll gain hands-on experience with industry guidelines and learn how cross-functional teams collaborate to achieve compliance.
What is an Internship in Computer System Validation (CSV)?
An Internship in Computer System Validation (CSV) is a temporary position, typically for students or recent graduates, that provides hands-on experience in ensuring that computer systems used in regulated industries (like pharmaceuticals or healthcare) meet required standards and regulations. Interns assist with validating software and hardware, documenting processes, and ensuring compliance with industry guidelines such as FDA 21 CFR Part 11 or EU Annex 11. This role helps interns understand the lifecycle of computer systems in a regulated environment and prepares them for careers in quality assurance, compliance, or IT within highly regulated sectors.
What is the difference between Internship Computer System Validation Csv vs Computer System Validation Specialist?
| Aspect | Internship Computer System Validation Csv | Computer System Validation Specialist |
|---|---|---|
| Credentials | Typically pursuing or recent graduate, basic understanding of validation | Relevant certifications (e.g., GAMP, ISPE), experience preferred |
| Work Environment | Internship setting, supervised, entry-level tasks | Full-time role, independent responsibilities in regulated industries |
| Industry Usage | Used in pharmaceutical, biotech, and medical device companies for training | Used for maintaining compliance, validating systems in regulated environments |
In summary, the Internship Computer System Validation Csv is an entry-level position focused on learning and supporting validation tasks, while the Computer System Validation Specialist is a more experienced role responsible for ensuring system compliance and validation in regulated industries.
What are the most commonly searched types of Computer System Validation Csv jobs in Indiana? The most popular types of Computer System Validation Csv jobs in Indiana are:
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What job categories do people searching Internship Computer System Validation Csv jobs in Indiana look for? The top searched job categories for Internship Computer System Validation Csv jobs in Indiana are:
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What cities in Indiana are hiring for Internship Computer System Validation Csv jobs? Cities in Indiana with the most Internship Computer System Validation Csv job openings:
Contractor
Posted 28 days ago
Job description
Job Title: Data Management Specialist – Aveva PI
Location: Indiana, IN (Hybrid)
Role: Contract
Duration: 12 Months
Key Responsibilities:
- Collaborate with site teams, Data Integrity champions, Engineering Tech Centres, and
- Technical Services to define data architectures and models
- Participate in the overall design of scalable and compliant data architecture
- Develop specifications and scope documents for data management initiatives
- Lead the execution and delivery of data management projects
- Oversee and coordinate with System Integrators executing data projects
- Work with technical departments to design process and asset templates supporting data
- models
- Identify equipment-specific data requirements for operations, maintenance, and
- reporting
- Ensure alignment of data management with information security protocols in
- collaboration with the Foundry Automation Technical Office
- Partner with Automation Project teams to integrate data solutions with existing system
- architecture and schedules
- Align data management efforts with Digital/MES workstreams
- Report progress, challenges, and support needs to the Foundry Automation Program
- Manager
- Address and resolve technical queries from system integrators
- Contribute to the creation of effective testing strategies for system validation
Basic Qualifications:
- Bachelor’s degree in Engineering
- 8+ years of data management experience in the pharmaceutical industry (API/bulk
- manufacturing preferred)
- Strong hands-on experience with Aveva PI, including:
- PI site infrastructure, data archive, and interfaces
- PI Asset Framework (Elements, Analyses, Event Frames, Notifications)
- PI Vision for dashboards and visualization
- Strong knowledge of GMPs, regulatory requirements, and computer system validation
- (CSV) principles
- Excellent verbal and written communication skills for both technical and non-technical
- audiences
- Proven ability to work collaboratively in cross-functional teams
Preferred Qualifications: - Experience integrating Aveva PI with automation systems (e.g., Emerson DeltaV Rockwell)
- Familiarity with OT systems and integration platforms (e.g., KepserverEx, MQTT message brokers such as HiveMQ)
- Experience with Logmate or equivalent alarm management systems
- Involvement in large-scale pharmaceutical automation programs/projects