We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation ...
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We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation ...
This role will lead the full Computer System Validation (CSV) lifecycle, ensuring compliance with FDA, EMA, and GAMP 5 requirements while partnering with Automation, IT, Engineering, and System ...
Quick apply
This role will lead the full Computer System Validation (CSV) lifecycle, ensuring compliance with FDA, EMA, and GAMP 5 requirements while partnering with Automation, IT, Engineering, and System ...
CSV Lead - (Delta-V and Rockwell)
Indianapolis, IN · On-site
$98K - $129K/yr
We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This ...
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CSV Lead - (Delta-V and Rockwell)
Indianapolis, IN · On-site
$98K - $129K/yr
We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This ...
Required : • Experience in Computer System Validation (CSV) standards • Ability to maintain Inspectional Readiness • Experience in participating in self-inspections, audits, and supplier ...
Required : • Experience in Computer System Validation (CSV) standards • Ability to maintain Inspectional Readiness • Experience in participating in self-inspections, audits, and supplier ...
Demonstrated experience in computer systems validation (CSV) for building management or automation and control systems in a pharmaceutical/GMP-regulated environment. * Strong knowledge of GAMP 5 ...
Demonstrated experience in computer systems validation (CSV) for building management or automation and control systems in a pharmaceutical/GMP-regulated environment. * Strong knowledge of GAMP 5 ...
Advise on validation strategy for future automation system upgrades and expansions. * Demonstrated experience in computer systems validation (CSV) for automation and control systems in a ...
Advise on validation strategy for future automation system upgrades and expansions. * Demonstrated experience in computer systems validation (CSV) for automation and control systems in a ...
CSV Engineer I
Indianapolis, IN · On-site
$68K - $88K/yr
We are looking for a CSV Computer System Validation Engineer who will support protocol execution for laboratory computer systems within a GxP manufacturing site. This individual should have a ...
CSV Engineer I
Indianapolis, IN · On-site
$68K - $88K/yr
We are looking for a CSV Computer System Validation Engineer who will support protocol execution for laboratory computer systems within a GxP manufacturing site. This individual should have a ...
CSV Engineer I
Indianapolis, IN · On-site
$68K - $88K/yr
We are looking for a CSV Computer System Validation Engineer who will support protocol execution for laboratory computer systems within a GxP manufacturing site. This individual should have a ...
CSV Engineer I
Indianapolis, IN · On-site
$68K - $88K/yr
We are looking for a CSV Computer System Validation Engineer who will support protocol execution for laboratory computer systems within a GxP manufacturing site. This individual should have a ...
CSV Engineer III
Indianapolis, IN · On-site
$68K - $88K/yr
This is a senior-level Computer System Validation (CSV) role for an experienced validation professional who will focus on executing CSV protocols for laboratory computerized systems in a GxP ...
CSV Engineer III
Indianapolis, IN · On-site
$68K - $88K/yr
This is a senior-level Computer System Validation (CSV) role for an experienced validation professional who will focus on executing CSV protocols for laboratory computerized systems in a GxP ...
CSV Engineer III
Indianapolis, IN · On-site
$68K - $88K/yr
This is a senior-level Computer System Validation (CSV) role for an experienced validation professional who will focus on executing CSV protocols for laboratory computerized systems in a GxP ...
CSV Engineer III
Indianapolis, IN · On-site
$68K - $88K/yr
This is a senior-level Computer System Validation (CSV) role for an experienced validation professional who will focus on executing CSV protocols for laboratory computerized systems in a GxP ...
Senior CSV Engineer
Indianapolis, IN · On-site
$115K - $135K/yr
... computer system validation, commissioning and qualification, data integrity, and regulatory ... Q and CSV documentation -- User Requirements, Functional and Design Specifications, Validation ...
Senior CSV Engineer
Indianapolis, IN · On-site
$115K - $135K/yr
... computer system validation, commissioning and qualification, data integrity, and regulatory ... Q and CSV documentation -- User Requirements, Functional and Design Specifications, Validation ...
Manager - Validation Lead - Technical Support & Operations - Global Services
Indianapolis, IN · On-site
Manager - Validation Lead - Technical Support & Operations - Global Services As a Senior Consultant - Validation, you will be responsible for driving Computer System Validation (CSV)/Computer ...
Manager - Validation Lead - Technical Support & Operations - Global Services
Indianapolis, IN · On-site
Manager - Validation Lead - Technical Support & Operations - Global Services As a Senior Consultant - Validation, you will be responsible for driving Computer System Validation (CSV)/Computer ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. * Develop and maintain system documentation, SOPs, training materials, and support guides ...
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 ...
In a GxP-regulated environment, this role uses Computer System Validation (CSV) procedures as a source of speed and business value, shaping scope, risk categorization, and validation strategy so that ...
In a GxP-regulated environment, this role uses Computer System Validation (CSV) procedures as a source of speed and business value, shaping scope, risk categorization, and validation strategy so that ...
Process Control & Automation Engineer (BMS/HVAC)
Lebanon, IN · On-site
$66K - $171K/yr
... System Validation (CSV). * 3+ years computer systems & software platforms administration. * Authorized to work in the U.S. full-time; no visa sponsorship. Additional Skills/Preferences
Process Control & Automation Engineer (BMS/HVAC)
Lebanon, IN · On-site
$66K - $171K/yr
... System Validation (CSV). * 3+ years computer systems & software platforms administration. * Authorized to work in the U.S. full-time; no visa sponsorship. Additional Skills/Preferences
Senior CSV Engineer
Indianapolis, IN · On-site
$99K - $137K/yr
About the Job Performance Validation is seeking a Senior CSV Engineer to join our Indianapolis team ... computer system validation, commissioning and qualification, data integrity, and regulatory ...
Senior CSV Engineer
Indianapolis, IN · On-site
$99K - $137K/yr
About the Job Performance Validation is seeking a Senior CSV Engineer to join our Indianapolis team ... computer system validation, commissioning and qualification, data integrity, and regulatory ...
In a GxP-regulated environment, this role uses Computer System Validation (CSV) procedures as a source of speed and business value, shaping scope, risk categorization, and validation strategy so that ...
In a GxP-regulated environment, this role uses Computer System Validation (CSV) procedures as a source of speed and business value, shaping scope, risk categorization, and validation strategy so that ...
Internship Computer System Validation Csv information
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 are the typical responsibilities of an intern in computer system validation (CSV)?
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 are the key skills and qualifications needed for an internship in computer system validation (CSV)?
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 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 popular job titles related to Internship Computer System Validation Csv jobs in Indiana?
For Internship Computer System Validation Csv jobs in Indiana, the most frequently searched job titles are:
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:
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:
Computer System Validation Engineer
Indianapolis, IN • On-site
Stark Pharma Solutions Inc
Contractor
Re-posted 16 days ago
Job description
Job Title: Validation Engineer
Location: Indianapolis / Bloomington, IN (100% Onsite)
Duration: Long term Contract
Interview Mode: Onsite (Local candidates preferred)
Job Summary:
We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.
Key Responsibilities
- Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
- Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
- Execute temperature mapping studies, including work with Ellab systems or similar equipment
- Support Computer Systems Validation (CSV) activities and documentation
- Assist Process Engineering teams to ensure project timelines and milestones are met
- Ensure all validation activities comply with GMP and regulatory requirements
- Maintain clear, accurate, and compliant documentation
Required Qualifications:
- Bachelor’s degree in Engineering, Science, or related field
- 6+ years of experience in Computer Systems Validation (CSV)
- 4+ years of experience in pharmaceutical manufacturing environment
- Hands-on experience with equipment qualification and validation
- Strong knowledge of CSV principles and regulatory compliance
- Experience working in onsite, fast-paced environments